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ROCKVILLE, Md. and SUZHOU, China, June 6, 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, autoimmune, metabolic, ophthalmology and other major diseases, and IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today jointly announced that the updated data from Phase 1b/2 study of Equecabtagene Autoleucel (Innovent R&D code: IBI326, IASO Bio R&D code: CT103A), a fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (RRMM), was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 2-6, 2023. Poster Presentation Overview Presentation Title: CT103A, a novel fully human BCMA-targeting CAR-T therapy, in patients with relapsed/refractory multiple myeloma: updated long-term follow-up results of phase 1b/2 study (FUMANBA-1) Session Title：Hematologic Malignancies—Plasma Cell Dyscrasia Abstract Code: ASCO-8025 Session date and Time: Monday, June 5, 2023, at 8:00 AM - 10:00 AM CDT Venue: McCormick Place, Chicago, Illinois, United States + Online The updated data showed long-term follow-up efficacy and safety of the Phase 1b/2 study (FUMANBA-1) conducted in 14 centers in China. This study enrolled RRMM patients who received ≥ 3 lines of prior therapies containing at least a proteasome inhibitor and an immunomodulatory agent and were refractory to their last line of treatment (ChiCTR1800018137, NCT05066646). As of the data cutoff date of September 9th, 2022, a total of 103 patients received CT103A at 1.0×106 CAR-T cells/kg with the median follow-up of 13.8 months (range 0.4, 27.2) and median prior four lines of therapy (range 3,23). Among the 103 patients, 68.9% (71/103) had high-risk cytogenetic abnormalities per mSMART 3.0, 12.6%（13/103）had extramedullary multiple myeloma (EMM), and 11.7%（12/103）had received prior CAR-T therapy. Equecabtagene Autoleucel showed deepening and durable efficacy: Among the 101 evaluable patients, the overall response rate (ORR) was 96.0% (97/101), with 91.1% (92/101) of those patients achieving very good partial response (VGPR) or deeper responses, and the stringent complete response/ complete response (sCR/CR) rate was 74.3% (75/101). The median time to response(mTTR) was 16 days (range 11-179). The median duration of response (DOR) and median progression free survival (PFS) have not been reached. The 12-month PFS rate was 78.8% (95% CI: 68.6–85.97). 95.0% (96/101) of patients achieved minimal residual disease (MRD) negativity, and all CR/sCR patients achieved MRD negativity. 82.4% (95%CI: 70.90-89.72%) of patients achieved sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached. In 89 patients without prior CAR-T therapy, ORR was 98.9% (88/89), including 78.7% (70/89) of patients reaching CR/sCR. Of the 63 patients with ≥ 12 months follow-up (including patients that withdrew early), ORR was 98.4% (62/93）and 87.3%（55/63）reached sCR/CR. Of the 12 patients with prior CAR-T therapy, 75% (9/12) achieved response, and 5 patients achieved sCR (including 4 patients that sustained sCR for over 18 months post-infusion). Equecabtagene Autoleucel demonstrated a favorable and manageable safety profile: Among the 103 patients, 93.2% (96/103) experienced cytokine release syndrome (CRS). The majority experienced grade 1~2 CRS, with only one experiencing ≥ grade 3 CRS. The median time to CRS onset was 6 days (range 1, 13) after infusion, and the median duration of CRS was 5 days (range 2, 30). Only two patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS. All patients with CRS or ICANS have recovered. The most common ≥ grade 3 treatment-related AEs were still hematologic. Equecabtagene Autoleucel demonstrated robust expansion and prolonged persistence and low immunogenicity: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 87570.6 copies/ug DNA. Equecabtagene Autoleucel was still detectable in 50% (28/56) and 40% (4/10) of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% (20/103) of the subjects were anti-drug antibody (ADA)-positive after Equecabtagene Autoleucel infusion. "Multiple myeloma (MM) is the second most prevalent hematological malignancy. While current major drug therapies such as proteasome inhibitors (PIs), immunomodulators (IMiDs) and monoclonal antibodies (mAbs) have significantly improved MM treatments in the past two decades, it is still an incurable disease. The updated data from our ongoing clinical study of Equecabtagene Autoleucel presented at ASCO demonstrated that treatment with our a BCMA-targeted CAR-T therapy was effective and well-tolerated for a longer period of time,"said principal investigators Prof. Lugui Qiu，MD，from the Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology." In comparison to the clinical data released at the EHA 2022 Congress, we're excited that our updated study data show that with the number of subjects receiving Equecabtagene Autoleucel increasing from 79 to 103, and the median follow-up time from 9.0 months to 13.8 months, Equecabtagene Autoleucel's efficacy further improved: the sCR/CR rate increased from 68.4% to 74.3%. It is more worth mentioning that the sCR/CR rate reached 87.3% in the subjects naïve to BCMA-targeted CAR-T therapies and followed up for at least 12 months. These results are encouraging and entails an opportunity to advance Equecabtagene Autoleucel to earlier lines of treatment to benefit more MM patients." About Multiple Myeloma (MM) Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there's currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases, and more than 2% of cancer-related deaths. According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025. About Equecabtagene Autoleucel Equecabtagene Autoleucel is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous screening and comprehensive in vivo and in vitro evaluation, Equecabtagene Autoleucel is proven to have potent and rapid anti-myeloma activity and outstanding safety, efficacy, and persistence results. Equecabtagene Autoleucel received New Drug Application (NDA) acceptance from China's National Medical Products Administration (NMPA) for the treatment of RRMM and obtained the U.S. FDA IND approval. The company also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) in February 2022 and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations in February 2023 from the FDA. In addition to multiple myeloma, NMPA has accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Innovent and IASO Bio are jointly developing Equecabtagene Autoleucel for the treatment of RRMM in mainland China. 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 injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection), Pemazyre® (pemigatinib oral inhibitor), olverembatinib(BCR ABL TKI), Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase III or pivotal clinical trials, and 18 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, Roche, 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. Disclaimer: Innovent does not recommend any off-label usage. 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. About IASO Biotechnology IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline includes a diversified portfolio of over 10 novel products, including IASO's leading asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection. In addition to Equecabtagene Autoleucel, the company's pipeline includes the fully developed in-house human CD19/CD22 dual-targeted CAR-T cell therapy which has received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). CD19/CD22 is currently in Phase I clinical trials for r/r B-NHL. It was also granted ODD by the FDA in October 2021. In the approximately 20 patients dosed to date in the investigator-initiated trial, there were no ICANS, or immune effector cell-associated neurotoxicity syndrome, of any grade observed in any patient, and a grade 3 cytokine release syndrome (CRS) rate of less than 5%, with the remainder of patients experiencing no CRS or less than grade 3. Leveraging its strong management team, innovative product pipeline, integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics. Innovent's 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, Inc. ("Innovent" or "Company") , 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 materialize or turn out to be incorrect.
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隨著疫情逐漸趨緩，對於非緊急醫療類的各種醫療產品需求也逐漸提升。台灣國際醫療暨照護展是一個 B2B 的展覽，該展在2023將重點關注專業輔助器材、數位醫療、醫療器材、醫療零件及醫療服務。對於國內、外的醫療器材製造商來說，它是重要的全球商業及營銷平台! 夏季逐漸來臨，高溫悶熱的天氣讓許多民眾在戴口罩時感到不適。為了解決這一困擾，達特世特別推出了夏日對策！革命性的羽量級口罩將於6/8(四) ~6/10 (六)於台北南港展覽館2館的「2023 台灣國際醫療暨健康照護展」全新上市，這是一款具有醫療防護級別，並兼具更好透氣效果的羽量級口罩。這款口罩不僅能有效降低夏季配戴口罩的悶熱感，更讓民眾在防疫期間兼顧舒適度。 達特世羽量級口罩的關鍵在於其HEPA等級的熔噴過濾層，使用與空氣清淨機濾網同等之HEPA（High-Efficiency Particulate Air，高效率空氣微粒子過濾網）等級過濾層，兼顧極高保護力、高透氣性及配戴舒適感，可高效率的過濾空氣中的粉塵微粒，實現高效防護。此外，輕薄的設計也有助於提高舒適性，減少緊貼臉部的悶熱感。販售顏色除了[ADB4] 原有的天空藍、櫻花粉之外[MOU5] ，我們更會依市場需求加碼推出新色，為你的夏日帶來舒暢感受，讓民眾為自己的健康把關之際，也能有舒適的配戴經驗。 本次，達特世生技有限公司將首度參與由中華民國對外貿易發展協會主辦的「2023台灣國際醫療暨健康照護展 Medical Taiwan」，歡迎醫療院所專業採購人員長照機構管理人士、及藥局經銷通路於6/8(四) ~6/10 (六)至攤位P0726洽談。歡迎各界朋友前來台北南港展覽館2館參觀並了解更多產品資訊。 在持續的防疫時期，當配戴口罩成為日常，選擇一款既能確保防護效果又能提高舒適度的口罩至關重要。我們除了保護呼吸道不受病菌侵擾，更要注意空汙為健康所帶來的危害。達特世口罩，讓我們在夏季不只能輕鬆應對防疫，更能應對空汙所帶來的挑戰，是各種情境的防護新選擇！
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