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82.4% of patients without prior CAR-T achieving Complete Response (CR) or better ROCKVILLE, Md. and SUZHOU, China, Sept. 28, 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, and IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced updated long-term follow-up data from two studies for BMCA CAR-T: ( 1) Results from phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel (Abstract Code P-290) and (2) A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T Treatment (Abstract Code P-288) at the 2023 International Myeloma Society (IMS) Annual Meeting in Vienna on September 27-30, 2023. Poster Presentation #1 Overview Presentation Title: Updated long-term follow-up results of a phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-290 Session Date and Time: Saturday, September 28, 2023, 12:30 PM - 1:30 PM EEST Equecabtagene Autoleucel is a chimeric antigen receptor T-cell (CAR-T) therapy featuring fully human B-cell maturation antigen (BCMA)-targeting single-chain fragment variable (scFv) antibody. The updated data showed long-term follow-up efficacy, safety, and persistence of the phase 1b/2 study (FUMANBA-1) conducted in 14 clinical sites in China. This study enrolled RRMM patients who had received ≥3 prior lines of therapy containing at least one proteasome inhibitor and one immunomodulator and whose disease had progressed after the last line of therapy (CTR20192510, NCT05066646). As of the data cutoff date of December 31, 2022, a total of 105 participants received Equecabtagene Autoleucel at 1.0×106 CAR-T cells/kg with a median follow-up of 18.07 months (IQR 12.6~21.8) and median prior four lines of therapy (range 3~23). Among the 105 patients, 69.5% (73/105) had high-risk cytogenetic abnormalities per mSMART 3.0, 13.3% (14/105) had extramedullary disease (EMD), and 11.4% (12/105) had received prior BCMA CAR-T therapy. Efficacy: Among the 103 evaluable patients, the overall response rate (ORR) was 96.1% (99/103), with 91.3% (94/103) of those participants achieving a very good partial response (VGPR) or deeper response, and the stringent complete response/complete response (sCR/CR) rate was 77.7% (80/103). In 91 participants without prior CAR-T therapy, ORR was 98.9% (90/91), 82.4% (75/91) of patients reaching sCR/CR, the 12-month PFS rate was 85.5% (95% CI: 75.75, 91.51). Among the 103 evaluable participants, the median time to response (mTTR) was 16 days (range 11, 179). The 12-month PFS rate was 80.0% (95% CI: 70.33,86.76). 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. 80.8% (95% CI: 69.59,88.24) of patients sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached. Equecabtagene Autoleucel demonstrated favorable efficacy in patients with multiple myeloma (MM) who had received prior CAR-T therapy. Among the 12 MM patients who previously received CAR-T therapy, the ORR was 75.0% (9/12), with 41.7% (5/12) of those patients achieving sCR. Safety: Among the 105 participants, 93.3% (98/105) 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 6.0 days (range 1, 13) post- infusion, and the median duration of CRS was 5.0 days (range 2, 30). Only 1.9% (2/105) of the patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS, with no ≥ grade 3 ICANS. All patients with CRS or ICANS have recovered. Expansion and Persistence: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 88001.13 copies/ug DNA. CAR Transgenes were still detectable in 50% (32/64) and 40% (4/10) of patients who completed follow-ups 12-month and 24-months after infusion. Anti-CAR antibodies developed in only 20 (19.2%) patients after infusion. Poster Presentation #2 Overview Presentation Title: A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T treatment Conference Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-288 Session Date and Time: September 28, 2023, 12:30 PM - 1:30 PM EEST Patients with RRMM treated with BCMA CAR-T cell therapy frequently experience hematologic toxicity of persistent thrombocytopenia. This presentation showcases a model that was developed to distinguish between patients at high and low risk for prolonged thrombocytopenia. The model was established after analyzing the baseline clinical characteristics of the participants, PLT, C reaction protein, plasma cells in bone marrow, hemoglobin, and Ig Ferritin—which were ultimately determined to be associated with the recovery of thrombocytopenia. Patients with a model score of 5 or higher post-infusion are at a higher risk for prolonged thrombocytopenia. The 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, stated, "Multiple myeloma is a hematology malignant disease with a high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need for treatments that are well-tolerated and with long persistence. Equecabtagene Autoleucel, a fully human targeted BCMA CAR-T injection, has demonstrated long-lasting efficacy with a durable response. In comparison to the clinical data released at the ASCO 2023 Annual Meeting, the updated study data at IMS shows that among patients without prior CAR-T therapy, ORR remains consistently high at 98.9%. The sCR/CR rate and 12-month PFS rate also significantly improved. This suggests that with longer follow-up periods and larger groups of participants, Equecabtagene Autoleucel continues to show excellent efficacy and safety. These results are encouraging and entail a promising opportunity to reshape RRMM treatment and bring forth new hopes to patients." About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 1 assets under NMPA NDA review, 7 assets in Phase III or pivotal clinical trials, and 18 more molecules in early clinical stage. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . 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. 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 materialize or turn out to be incorrect. SOURCE Innovent Biologics

82.4% of patients without prior CAR-T achieving Complete Response (CR) or better SHANGHAI and NANJING, China and SAN JOSE, Calif., Sept. 28, 2023 /PRNewswire/ -- IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, and Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, today announced updated long-term follow-up data from two studies for BMCA CAR-T: (1) Results from phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel (IASO Bio R&D code: CT103A, Innovent R&D code: IBI326, Abstract Code P-290) and (2) A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after anti-BCMA CAR-T Treatment (Abstract Code P-288) at the 2023 International Myeloma Society (IMS) Annual Meeting in Vienna on September 27-30, 2023. Poster Presentation #1 Overview Presentation Title: Updated long-term follow-up results of a phase 1b/2 study (FUMANBA-1) in patients with relapsed/refractory multiple myeloma (RRMM) treated with Equecabtagene Autoleucel Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-290 Session Date and Time: Saturday, September 28, 2023, 12:30 PM - 1:30 PM EEST CT103A (Equecabtagene Autoleucel) is a chimeric antigen receptor T-cell (CAR-T) therapy featuring fully human B-cell maturation antigen (BCMA)-targeting single-chain fragment variable (scFv) antibody. The updated data showed long-term follow-up efficacy, safety, and persistence of the phase 1b/2 study (FUMANBA-1) conducted in 14 clinical sites in China. This study enrolled RRMM patients who had received ≥3 prior lines of therapy containing at least one proteasome inhibitor and one immunomodulator and whose disease had progressed after the last line of therapy (CTR20192510, NCT05066646). As of the data cutoff date of December 31, 2022, a total of 105 participants received Eque-ce at 1.0×106 CAR-T cells/kg with a median follow-up of 18.07 months (IQR 12.6~21.8) and median prior four lines of therapy (range 3~23) Among the 105 patients, 69.5% (73/105) had high-risk cytogenetic abnormalities per mSMART 3.0, 13.3% (14/105) had extramedullary disease (EMD), and 11.4% (12/105) had received prior BCMA CAR-T therapy. Efficacy: Among the 103 evaluable patients, the overall response rate (ORR) was 96.1% (99/103), with 91.3% (94/103) of those participants achieving a very good partial response (VGPR) or deeper response, and the stringent complete response/complete response (sCR/CR) rate was 77.7% (80/103). In 91 participants without prior CAR-T therapy, ORR was 98.9% (90/91), 82.4% (75/91) of patients reaching sCR/CR,the 12-month PFS rate was 85.5% (95% CI: 75.75, 91.51). Among the 103 evaluable participants, the median time to response (mTTR) was 16 days (range 11, 179). The 12-month PFS rate was 80.0% (95% CI: 70.33,86.76). 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. 80.8% (95% CI: 69.59,88.24) of patients sustained MRD negativity over 12 months and the median duration of MRD negativity was not reached. Equecabtagene Autoleucel demonstrated favorable efficacy in patients with multiple myeloma (MM) who had received prior CAR-T therapy. Among the 12 MM patients who previously received CAR-T therapy, the ORR was 75.0% (9/12), with 41.7% (5/12) of those patients achieving sCR. Safety: Among the 105 participants, 93.3% (98/105) 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 6.0 days (range 1, 13) post-infusion, and the median duration of CRS was 5.0 days (range 2, 30). Only 1.9% (2/105) of the patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), including one grade 1 and one grade 2 ICANS, with no ≥ grade 3 ICANS. All patients with CRS or ICANS have recovered. Expansion and Persistence: Equecabtagene Autoleucel in peripheral blood reached the peak at a median of 12 days post-infusion, with a median Cmax of 88001.13 copies/ug DNA. CAR Transgenes were still detectable in 50% (32/64) and 40% (4/10) of patients who completed follow-ups 12-month and 24-months after infusion. Anti-CAR antibodies developed in only 20 (19.2%) patients after infusion. Poster Presentation #2 Overview Presentation Title: A model to predict the risk of prolonged thrombocytopenia recovery in relapsed/refractory multiple myeloma patients after antiBCMA CAR-T treatment Conference Session Title: Treatment of Relapsed/Refractory Multiple Myeloma Abstract Code: P-288 Session Date and Time: September 28, 2023, 12:30 PM - 1:30 PM EEST Patients with relapsed/refractory multiple myeloma (RRMM) treated with anti-B cell maturation antigen (BCMA) chimeric antigen receptor-T (CAR-T) cell therapy frequently experience hematologic toxicity of persistent thrombocytopenia. This presentation showcases a model that was developed to distinguish between patients at high and low risk for prolonged thrombocytopenia. The model was established after analyzing the baseline clinical characteristics of the participants, PLT, C reaction protein, plasma cells in bone marrow, hemoglobin, and Ig Ferritin—which were ultimately determined to be associated with the recovery of thrombocytopenia. Patients with a model score of 5 or higher post-infusion are at a higher risk for prolonged thrombocytopenia. "Multiple myeloma is a hematology malignant disease with a high incidence rate, and relapse and refractory are almost inevitable after current treatments. There's an urgent unmet need for treatments that are well-tolerated and with long persistence. Equecabtagene Autoleucel, a fully human targeted BCMA CAR-T injection, has demonstrated long-lasting efficacy with a durable response. In comparison to the clinical data released at the ASCO 2023 Annual Meeting, our updated study data at IMS shows that among patients without prior CAR-T therapy, ORR remains consistently high at 98.9%. The sCR/CR rate and 12-month PFS rate also significantly improved. This suggests that with longer follow-up periods and larger groups of participants, Equecabtagene Autoleucel continues to show excellent efficacy and safety. These results are encouraging and entail a promising opportunity to reshape RRMM treatment and bring forth new hopes to patients," 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. About IASO Bio IASO Bio is a biopharmaceutical company engaged in the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercial production. The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RR MM. Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit or . About Innovent Biologics Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, we have 1 asset under NMPA NDA review, 7 assets in Phase III or pivotal clinical trials, and 18 more molecules in early clinical stage. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Contact: IASO Bio Media: pr@iasobio.com Investors: ir@iasobio.com Innovent Biologics Media: pr@innoventbio.com +86 512-6956 6088 Investors: ir@innoventbio.com +86 512-6956 6088 View original content to download multimedia: SOURCE IASO Bio

12月21日，中国国家药监局药品审评中心（CDE）官网公示，由AkaRx公司、复星医药联合申报的马来酸阿伐曲泊帕片上市申请获得受理。公开资料显示，阿伐曲泊帕是复星医药引进的一款口服血小板生成素受体激动剂（TPO-RA），已经于2020年7月在中国获批上市，用于择期行诊断性操作或者手术的慢性肝病相关血小板减少症的成年患者治疗。 阿伐曲泊帕是一款血小板生成素受体激动剂（TPO-RA），已经获得美国FDA、欧洲EMA批准，拥有慢性肝病患者相关的血小板减少症（CLDT）、原发免疫性血小板减少症（ITP）双适应症。据复星医药公开资料介绍，阿伐曲泊帕可短时间内（治疗后3-5天）快速提升血小板计数。并且，不受食物类型限制的口服用药方式，大大提高了血小板减少症患者的生活质量。根据中国药物临床试验登记与信息公示平台官网，复星医药等公司正在开展一项国际多中心（含中国）3期临床试验，评估阿伐曲泊帕治疗活动性非血液系统肿瘤患者化疗所致血小板减少症的疗效和安全性。今年9月，一项“阿伐曲泊帕用于治疗实体瘤患者化疗引起的血小板减少症（CIT）“的多中心、开放标签、单臂临床试验”成果在Frontiers In Pharmacology期刊全文发表。 CIT的临床危害较多，包括化疗延迟、化疗减量、自发性出血风险增加、并发症及死亡率增加。CIT既往主要采用血小板输注和/或促血小板生长因子进行治疗，但上述治疗方案仍存在一定局限性。TPO-RAs则具有相似的升高血小板机制，其中阿伐曲泊帕在某些方面存在明显优势，如无潜在肝毒性基团，不增加肝脏不良事件风险；与食物同服，无饮食限制；保证药效同时兼顾便利性和安全性等。 阿伐曲泊帕治疗实体瘤CIT的研究纳入上一个化疗周期后发生过Ⅱ级血小板减少症（10×109/L＜PLT计数＜75×109/L）的人群，给予阿伐曲泊帕（60mg/天），同时根据患者情况给药5-10天。主要终点为阿伐曲泊帕起始治疗后，观察周期内血小板计数≥100×109/L或血小板计数较基线计数上升≥50×109/L或血小板计数较基线计数上升百分比≥100%患者比例。据复星医药早先新闻稿介绍，该研究为TPO-RAs治疗化疗所致血小板减少症（CIT）提供有力证据支持。在CIT患者中应用阿伐曲泊帕可使患者的血小板计数较基线显著增加，加速实体瘤患者化疗后血小板减少的恢复，且安全性和耐受性良好。 具体而言，阿伐曲泊帕治疗后，70.3%（52/74）的患者达到主要疗效指标。此外，累计有效率随时间不断提升，第1周有效率为37.8%（28/74)，第2周累计有效率为63.5%（47/74) ，第3周累计有效率为68.9% (51/74)。安全性结果提示，阿伐曲泊帕治疗后，仅少数患者出现不良事件，以恶心（8.1%）、疲劳（5.4%）为主，各不良事件发生率和阿伐曲泊帕说明书当中报道的基本一致。本次阿伐曲泊帕递交新适应症上市申请，意味着它有望在获批后惠及更多的患者。 参考资料：[1] 中国国家药监局药品审评中心（CDE）官网. Retrieved Dec 22，2022, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]苏可欣®商业上市两周年，惠及数万名血小板减少症患者 内容来源于网络，如有侵权，请联系删除。