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美國羅克維爾和中國蘇州2023年5月8日 /美通社/ -- 信達生物製藥集團（香港聯交所股票代碼：01801），一家致力於研發、生產和銷售腫瘤、自免、代謝、眼科等重大疾病領域創新藥物的生物製藥公司，宣佈其研發的重組抗胰島素樣生長因子1受體（IGF-1R）抗體注射液（研發代號：IBI311）在治療甲狀腺眼病（Thyroid Eye Disease, TED）的III期臨床研究（RESTORE）中完成首例受試者給藥。 RESTORE（CTR20223393）是一項在TED受試者中開展的隨機、雙盲、安慰劑對照的III期臨床研究，主要目的是評估IBI311改善TED受試者突眼的療效，以支持IBI311的上市註冊申報。主要研究終點為第24周時，研究藥物組受試者研究眼的眼球突出度改善應答率相對於安慰劑組的差異。 IBI311是信達生物製藥研發的靶向IGF-1R的單克隆抗體，用於治療甲狀腺眼病，目前國內尚未有針對TED的生物制劑獲批。IBI311可阻斷IGF-1與 IGF-1R結合，抑制IGF-1R介導的信號通路激活，減少下游炎症因子的表達，從而抑制眼眶成纖維細胞（OFs）的活化及其活化導致的透明質酸和其他糖胺聚糖的合成，減輕眼外肌和眼眶軟組織的炎症反應；抑制OFs分化為脂肪細胞或肌成纖維細胞，進而減輕TED患者的疾病活動度，改善突眼、復視、眼部充血水腫等症狀。 該臨床研究的主要研究者，中國工程院院士，上海交通大學醫學院附屬第九人民醫院眼科范先群教授表示：「甲狀腺眼病是成年人最常見的眼眶病之一，是與甲狀腺疾病密切相關的一種器官特異性自身免疫性疾病，可嚴重影響患者的視功能和外觀。當前國內尚無靶向藥物獲批用於治療甲狀腺眼病。IBI311在已經開展的臨床II期中已經觀察到了顯著的療效信號，包括突眼的回退和疾病活動性評分（clinical activity score, CAS）的改善，並展現了良好的安全性特徵，這給研究者帶來了很大的信心，我非常期待由國內創新藥企業開發的IBI311能在RESTORE研究中繼續展現出良好的有效性和安全性，並盡快上市，減輕患者病痛。」 信達生物製藥集團臨床開發副總裁錢鐳博士表示：「當前中國尚無靶向藥物獲批用於治療甲狀腺眼病，該領域有著極大的未滿足的臨床需求。IBI311是信達生物在眼科領域自主研發的又一新靶點分子，具有較高的成藥性，也與我們內分泌代謝領域佈局潛在協同。體外及臨床前動物研究已經初步驗證了IBI311具有良好的安全性及生物學活性；在健康人群中開展的I期臨床研究同樣提示IBI311具有良好的安全性及耐受性；在TED受試者中開展的II期臨床研究已觀察到了顯著的療效信號，並具有良好的安全性和耐受性特徵，這為III期臨床研究RESTORE的開展奠定了良好的基礎。信達將與學術界繼續通力合作，在范院士引領下全力推動IBI311的臨床開發。信達將在III期研究完成後快速遞交上市申請，把高質量、高可及性的生物藥帶給中國TED患者。」 關於甲狀腺眼病（TED） TED是一種累及眼部組織的自身免疫性疾病，通常伴發於毒性瀰漫性甲狀腺腫（Graves病，GD），是成人中最常見的眼眶相關疾病。TED可見於大約25~50%的GD患者，也可見於其他甲狀腺疾病，甚至甲狀腺功能正常者1。 TED的年發病率預估為16/100,000人（女性）和2.9/100,000人（男性）2。按照疾病嚴重程度，可分為輕度、中重度和極重度。雖然TED更常發生於女性，但重度病例更常發生於男性。TED最常見於30~50歲的患者，嚴重TED病例更常發生於50歲以上的患者3。目前，TED的發病機制尚不完全清楚，但多項研究表明，存在於肌纖維、眼眶纖維結締組織間隙中的OFs是導致TED眼眶軟組織增生的關鍵因素4。 TED的自然病程分為活動期和非活動期5。最常見的症狀是眼干、眼部異物感、畏光、流淚、復視和眼後壓迫感，而典型的體征包括眼球突出、上眼瞼退縮、眼瞼水腫、眶周組織和球結膜水腫。TED通常為輕度到中重度，約3~5%的TED患者會發展至極重度，表現為威脅視力的角膜潰瘍或壓迫性視神經病變等6。除了可能影響外觀和視功能，TED對患者的社交功能和生活質量產生極其嚴重的影響。 目前，中重度活動性TED的一線治療方案為糖皮質激素靜脈衝擊治療，存在突眼改善不理想以及激素相關的全身副作用等問題，仍存在較大的未滿足的臨床需求。二線治療包括再次激素衝擊或聯合眼眶放療或其他免疫調節劑。替妥木單抗（Teprotumumab）、托珠單抗（TociIizumab）和利妥昔單抗（Rituximab）等生物制劑也被EUGOGO 指南7和中國甲狀腺眼病臨床診斷和治療指南（2022年）8和美國甲狀腺學會和歐洲甲狀腺學會的甲狀腺眼病共識9推薦為中重度活動性TED的二線治療方案。尤其是對於合併顯著突眼的TED，替妥木單抗（Teprotumumab）可作為首選。 關於IBI311 IBI311是信達生物製藥研發的重組抗胰島素樣生長因子1受體（IGF-1R）抗體，用於治療TED。IGF-1R是一種跨膜酪氨酸激酶受體，在發育、代謝及免疫調節中發揮作用，並在TED患者的OFs、B細胞、T細胞中過表達10。IBI311可阻斷IGF-1等相關配體或激動型抗體介導的 IGF-1R 信號通路激活，減少下游炎症因子的表達，從而抑制OFs 活化導致的透明質酸和其他糖胺聚糖合成，減輕炎症反應；抑制OFs 分化為脂肪細胞或肌成纖維細胞，進而減輕TED患者的疾病活動度，改善突眼、復視、眼部充血水腫等症狀和體征。 關於信達生物 「始於信，達於行」，開發出老百姓用得起的高質量生物藥，是信達生物的理想和目標。信達生物成立於2011年，致力於開發、生產和銷售腫瘤、自身免疫、代謝、眼科等重大疾病領域的創新藥物。2018年10月31日，信達生物製藥在香港聯合交易所有限公司主板上市，股票代碼：01801。自成立以來，公司憑借創新成果和國際化的運營模式在眾多生物製藥公司中脫穎而出。建立起了一條包括35個新藥品種的產品鏈，覆蓋腫瘤、自身免疫、代謝、眼科等多個疾病領域，其中7個品種入選國家「重大新藥創製」專項。公司已有 8個產品獲得批准上市，它們分別是信迪利單抗注射液（達伯舒®），貝伐珠單抗注射液（達攸同®），阿達木單抗注射液（蘇立信®），利妥昔單抗注射液（達伯華®），佩米替尼片（達伯坦®），奧雷巴替尼片（耐立克®）， 雷莫西尤單抗注射液（希冉擇®），塞普替尼膠囊（睿妥®），3個品種在NMPA審評中，5個新藥分子進入III期或關鍵性臨床研究，另外還有19個新藥品種已進入臨床研究。信達生物已組建了一支具有國際先進水平的高端生物藥開發、產業化人才團隊，包括眾多海歸專家，並與美國禮來製藥、賽諾菲、Adimab、Incyte和MD Anderson 癌症中心等國際合作方達成28項戰略合作。 信達生物在不斷自研創新藥物、謀求自身發展的同時，秉承經濟建設以人民為中心的發展思想。多年來，始終心懷科學善念，堅守「以患者為中心」，心繫患者並關注患者家庭，積極履行社會責任。公司陸續發起、參與了多項藥品公益援助項目，讓越來越多的患者能夠得益於生命科學的進步，用得上、用得起高質量的生物藥。至2023年3月，信達生物患者援助項目已惠及16余萬普通患者，藥物捐贈總價值數億元。 信達生物希望和大家一起努力，提高中國生物製藥產業的發展水平，以滿足百姓用藥可及性和人民對生命健康美好願望的追求。 詳情請訪問公司網站：www.innoventbio.com或公司領英賬號www.linkedin.com/company/innovent-biologics/。 聲明：信達不推薦任何未獲批的藥品/適應症使用。 前瞻性聲明 本新聞稿所發佈的信息中可能會包含某些前瞻性表述。這些表述本質上具有相當風險和不確定性。在使用「預期」、「相信」、「預測」、「期望」、「打算」及其他類似詞語進行表述時，凡與本公司有關的，目的均是要指明其屬前瞻性表述。本公司並無義務不斷地更新這些預測性陳述。 這些前瞻性表述乃基於本公司管理層在做出表述時對未來事務的現有看法、假設、期望、估計、預測和理解。這些表述並非對未來發展的保證，會受到風險、不確性及其他因素的影響，有些乃超出本公司的控制範圍，難以預計。因此，受我們的業務、競爭環境、政治、經濟、法律和社會情況的未來變化及發展的影響，實際結果可能會與前瞻性表述所含資料有較大差別。 本公司、本公司董事及僱員代理概不承擔 (a) 更正或更新本網站所載前瞻性表述的任何義務;及 (b) 若因任何前瞻性表述不能實現或變成不正確而引致的任何責任。 參考文獻： 1. Li Z, Cestari D M, Fortin E. Thyroid eye disease: what is new to know? Curr Opin Ophthalmol. 2018;29(6):528-534. 2. Bartley G. The epidemiological characteristics and clinical course of ophthalmology associated with autoimmune thyroid disease in Olmsted Country, Minnesota. Trans Am Ophthalmol Soc 1994;92:477-588. 3. Edsel I. Thyroid Associated Orbitopathy. Retrieved June 7, 2011, from Medscape Reference: http://emedicine.medscape.com/article/1218444-overview#a1 4. Ali F, Chorsiya A, Anjum V, Ali A. Teprotumumab (TEPEZZA): from the discovery and development of medicines to USFDA approval for active thyroid eye disease (TED) treatment. Int Ophthalmol. 2021;41(4):1549-1561. 5. Dolman P J. Evaluating Graves' orbitopathy. Best Pract Res Clin Endocrinol Metab.2012;26(3):229-248. 6. Bahn R S. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738. 7. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67. 8. 中華醫學會眼科學分會眼整形眼眶病學組, 中華醫學會內分泌學分會甲狀腺學組. 中國甲狀腺相關眼病診斷和治療指南 （2022年）.中華眼科雜誌. 2022;58(9). 9. Burch HB, et al. Management of thyroid eye disease: a Consensus Statement by the American Thyroid Association and the European Thyroid Association. Eur Thyroid J. 2022;11(6):e220189. 10. Douglas RS, Naik V, Hwang CJ, et al. B cells from patients with Graves' disease aberrantly express the IGF-1 receptor: implications for disease pathogenesis. J Immunol 2008;181:5768-5774.
Lupus awareness tools, facts and resources available at WorldLupusDay.org/tool-kit WASHINGTON, May 8, 2023 /PRNewswire/ -- World Lupus Day was established to take place on May 10 by the World Lupus Federation (WLF) to unite lupus groups around the world during Lupus Awareness Month and call attention to the impact that the disease has on the more than 5 million people globally affected by lupus. This year on May 10 for World Lupus Day, the World Lupus Federation is urging the global public, including those living with lupus, their friends and family members to raise awareness and share facts about the disease on social media and in their communities. Lupus is a chronic autoimmune disease that can cause inflammation and pain in any part of the body, including the heart, kidney, lungs, blood, joints and skin. With lupus, the immune system, the body system that usually fights infections, attacks healthy tissue. While anyone can develop lupus, 90% of people with the disease are women. It has no known causes or cure, and can be disabling and potentially fatal. Access to care and medications continue to be a significant challenge for people with lupus around the world. A recent WLF global survey found that 1 in 4 respondents delayed or did not get medical care when needed in the last 12 months, with top reasons including wait times (44%), fatigue (22%), cost (22%). Those that delayed or did not get care also were twice as likely to have multiple flares, a time when lupus symptoms, such as pain and inflammation, worsen. "World Lupus Day is an incredibly important opportunity to raise awareness of the physical, emotional and economic impact that lupus can have," shared Professor Syed Atiqul Haq, President, Lupus Foundation of Bangladesh, and member of the eight-nation WLF steering committee. "For many in Bangladesh and around the world, lupus isn't understood, which can lead to delayed diagnosis and for those living with the disease to feel misunderstood and unable to receive the care they need for this debilitating disease. Each voice sharing facts on World Lupus Day can have an incredible impact and bring greater attention and resources to efforts to end lupus." The World Lupus Federation is encouraging people around the globe to share facts about lupus and raise awareness on May 10 for World Lupus Day using the official toolkit, whether it's by contacting local media and policymakers or through an individual's social media channels. The toolkit offers several awareness resources and tools, including social media shareables in English and Spanish. People across the globe are also encouraged to wear purple and have buildings lit purple to shine a light on the fight to end lupus. Find out how to get involved on World Lupus Day at worldlupusday.org and check out the official toolkit for ways to participate. About the World Lupus FederationThe World Lupus Federation (WLF) is a coalition of lupus patient organizations, united to improve the quality of life for all people affected by lupus. Through coordinated efforts among its affiliates, the Federation works to expand global initiatives that create greater awareness and understanding of lupus, provide education and services to people living with the disease and advocate on their behalf. MEDIA CONTACTMike DonnellyWorld Lupus Federation donnelly@lupus.org
SHANGHAI, May 8, 2023 /PRNewswire/ -- On May 6th, the "2023 Commencement Ceremony for Major Industrial Projects in Fengxian and for Duoning's Global Headquarters and Industrialization Base" was held grandly in the Biotechnology Park. Leaders of the Fengxian district, representatives of the Oriental Beauty Valley and Duoning Biotech attended to witness this important moment. The global headquarters of Duoning biotech is located in the heart of the Biotechnology Park, with a total construction area of over 40,000m2, including an office building, an R&D center, a technology application center and supporting facilities. Based on the unique innovation ecology of the Park, it will provide high quality and cost effective equipment, consumables and services to the biopharmaceutical industry after completion. According to Li Lei, Deputy District Mayor of Fengxian, "the Several Policies for Promoting High Quality Development of Life and Health Industry in Fengxian District released in last April shows our determination and confidence to unswervingly develop biomedicine and other leading industries. Improving business environment should be the key to the development of the entire district and enterprises here. We must create a favorable environment and broad space for market players in an all-round way, promote projects in key areas to gather momentum in Fengxian, and contribute to China's modernization drive." "The global headquarters will be our first industrialization base integrate R&D, business operation and technical application. Our headquarters, driven by the market demand and policies, will empower the entire life cycle of biologics. In the service dimension, we will actively collaborate with outstanding life science companies around the world to provide one-stop solutions for research institutions, CROs/CDMOs and biopharmaceutical companies. And in the industry dimension, we will help our partners achieve asset-light operation with a diversified portfolio of products & services, and help connect the entire biopharmaceutical industries upstream to downstream in Fengxian," said Wang Meng, CEO and Chairman of Duoning Biotech. Zhou Ruyi, Party Secretary and Chairman of the Oriental Beauty Valley, said, "Duoning is our important partner in building biomedical industry chain and developing high-value consumables in the core area of the Valley, and it was selected as a representative firm in the Shanghai Biomedical Industry Investment Guide 2023. As an important part of Shanghai's '1+5+X' biomedical industry layout, the Oriental Beauty Valley will firmly implement the development tenet of ensuring 'Sufficiency for Five Goods'[1]. With the orderly advancement of high-quality projects represented by Duoning, it will inject new impetus into the formation of a highland for industry agglomeration." About Duoning Shanghai Duoning Biotechnology Co., Ltd. is a leading one-stop shop dedicated to providing integrated bioprocess solutions from the development to the commercialization of biologics products in China. we operate two main business segments, bioprocess solutions and laboratory products and relative services, and seek to help partners achieve efficient, stable, high-quality and cost-controllable drug development and manufacturing processes. For more information, please visit: www.duoningbio.com. [1] Sufficiency for Five Goods: Sufficient land for good projects, sufficient space for good industries, sufficient scenarios for good applications, sufficient talents for good ideas and sufficient resources for good teams
ROCKVILLE, Md. and SUZHOU, China, May 8, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that second interim analysis and survival analysis results of the ORIENT-31 study (NCT03802240) have been published in the Lancet Respiratory Medicine (https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(23)00135-2/fulltext). This randomized, double-blinded, multi-center Phase 3 study evaluated TYVYT®(sintilimab) with or without anti-VEGF antibody therapy (BYVASDA® [bevacizumab injection]) combined with chemotherapy (pemetrexed and cisplatin) in patients with EGFR-mutated non-squamous non-small cell lung-cancer (NSCLC) who progressed after EGFR-TKI therapy. The first interim analysis has been published in the Lancet Oncology in 2022i. In the second interim analysis (data cutoff date: March 31th, 2022), the main purpose is to analyze the median progression-free survival (mPFS) of the preset sintilimab plus chemotherapy group (Arm B) versus chemotherapy group (Arm C) in the intent-to-treat (ITT) population, update the results of sintilimab plus bevacizumab plus chemotherapy group (Arm A) and report the overall survival results of the study for the first time. The median follow-up duration of progression-free survival (PFS) were 12.9 months, 15.1 months, and 14.4 months in Arm A, Arm B and Arm C, respectively. Based on the assessment by the Independent Radiographic Review Committee (IRRC), the median PFS were 7.2 months (95%CI: 6.6, 9.3) in Arm A, 5.5 months (95%CI: 4.5, 6.1) in Arm B, and 4.3 months (95%CI: 4.1, 5.3) in Arm C. Arm B demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Arm C, with a HR of 0.72 (95%CI: 0.55, 0.94, P=0.016), which reached pre-specified superiority boundary value. Significant PFS benefit was sustained in Arm A compared to Arm C with a HR of 0.51 (95%CI: 0.39, 0.67, p<0.0001). As of data cutoff July 4th, 2022, a trend towards overall survival (OS) benefit with Arm A was observed although the median OS for Arm C was prolonged due to crossover after progression in Arm C. The median OS for Arm A and Arm C were 21.1 months vs 19.2 months, HR=0.98. After adjusting for crossover, the OS HR ranged from 0.79 to 0.84. In the exploratory analyses of quality of life, Arm A showed longer median time-to-deterioration of the Global Health Status Dimension Score of EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) compared with Arm C. The safety results were generally consistent with those in the first interim analysis; in particular, treatment-related adverse events of grade ≥3 were 56% in Arm A, 41% in Arm B and 49% in Arm C. The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and bevacizumab, without new or unexpected safety signals. Globally, ORIENT-31 is the first multi-center, double-blind, prospective Phase 3 study to demonstrate significant PFS benefit of combination therapy of an anti-PD-1 antibody with chemotherapy in patients with EGFR mutated nsqNSCLC that progressed on prior EGFR-TKI therapy. Sintilimab and chemotherapy group showed significant improved PFS with an optimal safety profile. With the extension of follow-up time, sintilimab plus bevacizumab and chemotherapy group continued to show a durable, clinically meaningful PFS benefit. The principal investigator of the ORIENT-31 Study, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, stated, " ORIENT-31 is globally the first prospective, randomized, double-blind Phase 3 study that demonstrated significant PFS benefit of combination therapy of anti-PD-1 antibody and chemotherapy with or without bevacizumab in patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy, which was revolutionary in immunotherapy. I am pleased to witness the first and second interim analysis results of the ORIENT-31 study were published in international authoritative and influential journals. Besides, I hope that the recent approval of sintilimab in combination with bevacizumab and chemotherapy in treatment of patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy can bring a new treatment option benefiting more cancer patients." Dr. Hui Zhou, Senior Vice President of Innovent, stated, "the ORIENT-31 study is the first Phase 3 study that met primary endpoints in the world evaluating efficacy of PD-1 inhibitor and chemotherapy with or without bevacizumab in patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy. The results of first and second interim analysis were published in the Lancet Oncology and the Lancet Respiratory Medicine, respectively. That represents the international academia's recognition of high quality, innovative clinical trial conducted by investigators in China, and is also a milestone marking Innovent's solid and outstanding capabilities in new drug development. Meanwhile, we look forward to the approval of sintilimab in combination with bevacizumab and chemotherapy based on the results of the ORIENT-31 study can bring new hope to patients with EGFR mutated non-squamous NSCLC that progressed on prior EGFR-TKI therapy. Innovent endeavors to advance innovative drug development targeting unmet medical needs, to bring more effective and affordable treatment options to patients in China and the world." About the ORIENT-31 Study ORIENT-31 is a randomized, double-blind, multi-center Phase 3 clinical study conducted in China evaluating sintilimab, with or without bevacizumab, combined with chemotherapy (pemetrexed and cisplatin) in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed following EGFR TKI treatment (ClinicalTrials.gov, NCT03802240). The primary endpoint is PFS as assessed by IRRC based on RECIST v1.1. The secondary endpoints include overall survival (OS), PFS as assessed by investigators, ORR and safety. About Sintilimab Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cellsii. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for six indications. The updated NRDL reimbursement scope description of TYVYT® (sintilimab injection) include: For the treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma; For the treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma; For the treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations; For the treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer; For the treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment; For the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy. Innovent currently has the regulatory submission for sintilimab in combination with bevacizumab biosimilar and chemotherapy for EGFR-TKI failed EGFR-mutated non-squamous NSCLC under review in the China's NMPA. Besides, two clinical studies of sintilimab have met their primary endpoints: Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma; Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy. About BYVASDA® (bevacizumab injection) BYVASDA® is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA® produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cellsiii. In China, BYVASDA® is approved and included in NRDL for seven indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, advanced or unresectable hepatocellular carcinoma, epithelial ovarian, fallopian tube, or primary peritoneal cancer and cervical cancer. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 19 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/. About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to create medicines to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels. About Eli Lilly and Company's strategic cooperation with Innovent Biologics Lilly entered into a strategic collaboration with Innovent focused on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Lilly and Innovent will co-develop and commercialize oncology medicines, including Tyvyt® (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology antibodies targeting oncology indications. In August 2019, Innovent further entered into a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization. In August 2020, Lilly and Innovent announced a global expansion of their strategic alliance for sintilimab. In March 2022, Lilly and Innovent deepened the strategic partnership in oncology, in which Innovent obtained the sole commercialization rights to import, market, promote, distribute and detail CYRAMZA® (ramucirumab) and Selpercatinib, and a right of first negotiation for potential future commercialization of pirtobrutinib in Mainland China. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA®, SULINNO®, and HALPRYZA® are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab injection, Innovent) HALPRYZA® (rituximab injection, Innovent) SULINNO® (adalimumab injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Disclaimer: INNOVENT does not recommend use of any unapproved drugs/indications. Innovent Biologics, Inc. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. References: i Lu S, Wu L, Jian H, et al. Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022;S1470-2045(22)00382-5. doi:10.1016/S1470-2045(22)00382-5. ii Wang J, Fei K, Jing H, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451. iii International Journal of Nanomedicine 2019:14 7643-7663
ROCKVILLE, MD. and SUZHOU, China, May 8, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first patient with Thyroid Eye Disease (TED) has been successfully dosed in the Phase 3 study (RESTORE) of IBI311, a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody. The RESTORE study (CTR20223393) is a randomized, double-blinded, placebo-controlled, phase 3 clinical study evaluating the efficacy of IBI311 in improving proptosis in TED subjects to support the potential new drug application of IBI311. The primary endpoint is the difference in the improvement in proptosis degree responder rate of the study eye in the treatment group compared with the placebo group at week 24. IBI311 is an IGF-1R targeting monoclonal antibody independently developed by Innovent for the treatment of TED. Currently no biological agent for TED has been approved in China. By blocking the binding of IGF-1 and IGF-2 to IGF-1R, IBI311 inhibits IGF-1R signaling pathway activation and reduces the expression of downstream inflammatory factors, thereby inhibiting the adipocytosis of orbital fibroblasts (OFs) and the synthesis of hyaluronic acid and other glycosaminoglycans due to the activation of OFs, as well as the inflammatory response, thus reduces disease activity and improve proptosis, diplopia, ocular congestion and edema in patients with TED. The principal investigator, Professor Fan Xianqun from Ophthalmology Department of the Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, an academician from the Chinese Academy of Engineering, stated: " TED is one of the most common orbital diseases in adults and is an organ-specific autoimmune disease closely related to thyroid disease, which can severely affect the visual function and appearance of patients. There are currently no targeted drugs approved for TED in China. Significant efficacy signals have been observed in IBI311 phase 2 clinical study, including the regression of exophthalmos and the improvement of the Clinical Activity Score (CAS), and a good safety profile was also demonstrated. We are confident that IBI311, developed by a domestic biopharmaceutical company, will demonstrate good efficacy and safety in the Chinese TED patients and be able to be launched to market as soon as possible to address patients' urgent needs." Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: "At present, there is a great unmet medical need for TED because of no targeted drug approved for TED in China. IBI311 is an ophthalmic drug candidate developed by Innovent for the treatment of TED with high druggability, and will potentially add synergic value to our product portfolio in endocrinology and metabolism field. Preclinical in vivo and in vitro studies, the Phase 1 study in healthy volunteers as well as the Phase 2 study in TED subjects demonstrated that IBI311 has favorable safety and tolerability characteristics, and significant efficacy signals were also observed, which has laid a good foundation for the development of Phase 3 RESTORE study. Innovent will continue cooperating with academia and advance clinical development under the leadership of Prof. Fan, and plans to submit the NDA after the Phase 3 study completion to bring high quality and accessible biologics to Chinese TED patients." About Thyroid Eye Disease (TED) TED is an autoimmune disease involving ocular tissues and is usually associated with Graves' disease (GD) and is the most common orbit-related disease in adults. TED occurs in approximately 25 to 50% of GD patients and can also be seen in other thyroid diseases, even in euthyroidism1. The annual incidence of TED is estimated to be 16/100,000 in women and 2.9/100,000 in men2. According to disease severity, it can be divided into mild, moderate and severe. Although TED appears to affect women more often, severe cases occur more frequently in men. Patients aged 30 to 50 years are most commonly affected, and severe cases occur more frequently in patients over 50 years3. At present, the pathogenesis of TED is not fully understood, but several studies have shown that OFs present in muscle fibers, orbital fibrous connective tissue space are key factors leading to orbital soft tissue enlargement in TED4. The natural history of TED is divided into active and inactive phases5. The most common symptoms are dry eye, ocular gritty, photophobia, lacrimation, diplopia, and pressure behind the eye, while typical signs include upper eyelid retraction, eyelid edema, periorbital and conjunctival edema, and proptosis. TED is usually mild to moderate, and about 3–5% of patients with TED are severe, manifesting as severe pain, vision-threatening corneal ulcers, or compressive optic neuropathy6. In addition to potentially affecting vision, TED can have an extremely severe impact on the patient's appearance and social functioning and quality of life. Currently, the first-line treatment option for moderately severe active TED is intravenous glucocorticoid therapy, which suffers from unsatisfactory improvement of proptosis and systemic side effects, and second-line treatment includes other immunomodulators, which also have risks related to unclear improvement of proptosis and treatment. Teprotumumab, TociIizumab and Rituximab are recommended by the Chinese Clinical Diagnosis and Treatment Guidelines for Thyroid Eye Disease (2022)7, the European Group On Graves' Orbitopathy (EUGOGO)8 and the consensus on thyroid eye disease of the American Thyroid Society and the European Thyroid Society9 as the second-line treatment options for moderate to severe active TED. Teprotumumab is recommended as first-line therapy for patients with clinically significant ophthalmopathy. About IBI311 IBI311 is a recombinant anti-IGF-1R antibody developed by Innovent Biopharmaceuticals for the treatment of TED. IGF-1R is a transmembrane tyrosine kinase receptor that plays a role in development, metabolism, and immune regulation, and is overexpressed in OFs, B, and T cells of TED patients10. IBI311 can bind IGF-1R, block IGF-1R signaling pathway activation mediated by IGF-1 and other related ligands or agonistic antibodies, reduce the expression of downstream inflammatory factors, thereby inhibiting the synthesis of hyaluronic acid and other glycosaminoglycan caused by OFs activation, as well as related inflammatory reactions including tissue congestion and edema; inhibit adipocyte cellularization of OFs, thereby reducing the disease activity of patients with TED and improving proptosis, diplopia, ocular congestion and edema and other symptoms and signs. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines in the fields of oncology, metabolism, autoimmunity,, ophthalmology and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 19 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/. Note: TYVYT® (sintilimab injection) is not an approved product in the United States. BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States. TYVYT® (sintilimab injection, Innovent) BYVASDA® (bevacizumab biosimilar injection, Innovent) HALPRYZA® (rituximab biosimilar injection, Innovent) SULINNO® (adalimumab biosimilar injection, Innovent) Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan. CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China. Disclaimer: Innovent does not recommend any off-label usage. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect. Reference: 1. Li Z, Cestari D M, Fortin E. Thyroid eye disease: what is new to know? Curr Opin Ophthalmol. 2018;29(6):528-534. 2. Bartley G. The epidemiological characteristics and clinical course of ophthalmology associated with autoimmune thyroid disease in Olmsted Country, Minnesota. Trans Am Ophthalmol Soc 1994;92:477-588. 3. Edsel I. Thyroid Associated Orbitopathy. Retrieved June 7, 2011, from Medscape Reference: http://emedicine.medscape.com/article/1218444-overview#a1 4. Ali F, Chorsiya A, Anjum V, Ali A. Teprotumumab (TEPEZZA): from the discovery and development of medicines to USFDA approval for active thyroid eye disease (TED) treatment. Int Ophthalmol. 2021;41(4):1549-1561. 5. Dolman P J. Evaluating Graves' orbitopathy. Best Pract Res Clin Endocrinol Metab.2012;26(3):229-248. 6. Bahn R S. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738. 7. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67. 8. 中华医学会眼科学分会眼整形眼眶病学组, 中华医学会内分泌学分会甲状腺学组. 中国甲状腺相关眼病诊断和治疗指南 （2022年）.中华眼科杂志. 2022;58(9). 9. Burch HB, et al. Management of thyroid eye disease: a Consensus Statement by the American Thyroid Association and the European Thyroid Association. Eur Thyroid J. 2022;11(6):e220189. 10. Douglas RS, Naik V, Hwang CJ, et al. B cells from patients with Graves' disease aberrantly express the IGF-1 receptor: implications for disease pathogenesis. J Immunol 2008;181:5768-5774.
Anthology's Annual Global Fix Your Content Day is May 18 BOCA RATON, Fla., May 8, 2023 /PRNewswire/ -- Anthology, a leading provider of education solutions that support the entire learner lifecycle, today announced its fourth annual Fix Your Content Day to highlight the need for more inclusive digital learning content. Anthology is inviting higher education institutions that use Anthology Ally to participate. The objective of Fix Your Content Day is to engage colleges and universities globally to make meaningful change in the lives of all students and create more inclusive learning environments. By participating in the competition, higher ed institutions and instructors are doing their part to improve the accessibility of course materials and demonstrate their commitment to inclusivity. "We look forward to participating in the 24-hour global competition each year, which challenges us to continue our journey in creating more inclusive digital learning content," said Coastal Pines Technical College Executive Vice President, Amanda Morris, the 2022 First Place Fix Your Content Day Global Winner. "While Fix Your Content Day is only once a year, our college and the Technical College System of Georgia collectively strives to improve the accessibility of course materials and serve as a champion for accessibility every day. Additionally, we enjoy the friendly competition with other colleges and encourage our faculty and staff to get involved. The challenge is a fun way to review our course content for quality and accessibility." More than 1,500 institutions around the world use Anthology Ally to enhance digital content on their learning management systems (LMS). The result is better learning outcomes for students by improving the usability, readability, and quality of the digital materials in their courses. "An estimated one billion people across the globe experience some sort of physical, visual, hearing, or cognitive disability. Employing solutions to create more accessible learning environments is imperative," said Anthology Chairman and CEO Jim Milton. "However, making content more accessible and providing alternative formats isn't just for a select group of students. Alternative formats generated by solutions like Anthology Ally provide greater opportunities for everyone to access the information they need in the way they want it. We are thrilled to see the enthusiasm of institutions and faculty participating in this global effort." Anthology Ally empowers learners with the flexibility of choosing the most effective way to interact with digital content. By dynamically enhancing learning materials for student preferences and needs, it automatically provides alternative formats for course content, like audio files, translations, PDFs better formatted for mobile devices and more, all without manual intervention from the institution or instructor. "While we've been actively supporting faculty and staff in centering inclusivity in their online courses for years, this will be our first year participating in Fix Your Content Day," said Dr. Hannah Digges Elliott, Senior Instructional Designer at Western Kentucky University. "We're excited about the opportunity to encourage a little competition among our faculty and staff and ultimately continue to highlight the importance of more accessible content." "We're thrilled to be a part of such a global initiative that unites the higher education community around a friendly competition and highlights the critical need for accessible, inclusive, and equitable online learning environments," said Dr. Chris Campbell, Sub Dean of Learning Technology at Charles Sturt University in Australia. "Fix Your Content Day highlights the importance of building equitable learning experiences," said Dr. Margaret Korosec, Dean of Online and Digital Education at the University of Leeds in the United Kingdom. "It's also a reminder to reflect on how learning experiences are received by students and how choice of access supports their requirements. Equitable access starts with our own awareness of what's possible and working to push the boundaries of what can be done in an accessible way." To participate in the 2023 Fix Your Content Day challenge, register your institution here: https://www.anthology.com/fix-your-content-day About Anthology Anthology offers the largest EdTech ecosystem on a global scale for education, recently combining with Blackboard to support more than 150 million users in 80 countries. With a mission to provide dynamic, data-informed experiences to the global education community, Anthology helps learners, leaders and educators achieve their goals through over 60 SaaS products and services designed to advance learning. Discover more about how we are fulfilling our mission for K-12, higher education, business and government institutions at www.anthology.com. CONTACT: Erin Mitchell, Anthology, Erin.Mitchell@anthology.com Photo - https://mma.prnasia.com/media2/2071292/Anthology_Ally_Formats.jpg?p=medium600Logo - https://mma.prnasia.com/media2/1708867/4023211/Anthology_Logo.jpg?p=medium600
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