CD8A

SHANGHAI and NANJING, China and SAN JOSE, Calif., July 2, 2023 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a clinical-stage 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 that China National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel, co-developed and co-commercialized by IASO Bio and Innovent, IASO Bio R&D code: CT103A, Innovent R&D code: IBI326), the world's first 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 (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent. FUCASO® (Equecabtagene Autoleucel) is an autologous BCMA CAR-T cell injection, transduced by a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. FUCASO® was given as a one-time treatment with a recommended dose of 1.0×106 CAR-T cells/kg. Based on strict selection and screening of the molecular structures, using a proprietary in-house optimization platform and integrated in-house manufacturing process, FUCASO® is potent and shows prolonged persistency in patients. It will bring new treatment options to R/R MM patients with higher and more profound responses. The NDA approval is based on the data from the pivotal FUMANBA-1 study (CTR20192510, NCT05066646) conducted at multiple sites in China. In June 2023, the updated data from FUMANBA-1 study was presented at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Abstract Number: 8025). The study enrolled 103 R/R MM patients with a median follow-up time of 13.8 (0.4, 27.2) months. Among the 101 evaluable patients, the overall response rate (ORR) was 96%, with the stringent complete response/ complete response (sCR/CR) rate of 74.3%. Median time to response (mTTR) was only 16 days, and the 12-month Progression-Free Survival (PFS) rate was 78.8%. 95% of the patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Of the 12 patients with prior CAR-T therapy, 9 achieved response, and 5 achieved sCR (including 4 patients achieved sustained sCR for over 18 months post-infusion). In 89 patients without prior CAR-T therapy, 78.7% reached sCR/CR. Of the 103 safety evaluable patients, only one experienced grade ≥3 cytokine release syndrome (CRS), and 2 experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). All patients with CRS or ICANS recovered after the treatment. FUCASO® was still detectable in 50% and 40% respectively of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% of the patients were anti-drug antibody (ADA)-positive. "There's a significant unmet medical need for the treatment of multiple myeloma in China. As a fully-human BCMA CAR-T therapy, FUCASO® has demonstrated remarkable efficacy, with evidence of deep and durable response. Its approval also offers clinicians more options to treat R/R MM patients after multi-lines of treatment," said Prof. Lugui Qiu, MD, Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, who is the principal investigators of the registration trial of FUCASO®. M s. Jinghua Zhang, Chairman and Chief Executive Officer of IASO Bio, stated, "We are excited that FUCASO® was approved, it is a significant milestone for the Company. FUCASO® is not only IASO Bio's first marketed product but is also the world's first commercially available fully-human CAR-T therapy. Furthermore, FUCASO® is the first self-developed and in-house manufactured CAR-T cell therapy in China as well as China's first approved BCMA CAR-T for the treatment of multiple myeloma. The NMPA NDA approval of FUCASO® will help us in achieving our strategic goal of bringing break through therapy to patients in unmet need, with the hope for a potential cure." Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, "Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are inevitable after current treatments. There's an urgent unmet need requesting a treatment with well-tolerated and long persistence for patients. FUCASO®, as an innovative fully-human cell therapy, has demonstrated robust and long-lasting efficacy and outstanding safety in long-term follow-up data from the registrational clinical study, which underscores its potential to be a pioneering treatment option for patients with RRMM. We are very pleased with the successful approval of FUCASO® and hope it could benefit RRMM patients as the first approved BCMA CAR-T therapy in China.." About Multiple Myeloma (MM) Multiple Myeloma (MM) is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For MM 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. According to Frost & Sullivan, new MM cases in China rose from 20,100 in 2018 to 22,400 in 2022 and are expected to increase to 25,700 by 2027. About IASO Bio IASO Bio is a clinical stage biopharmaceutical company engaged in discovery and development of novel cell therapies and biologics 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 portfolio of over 10 novel products, including FUCASO® (Equecabtagene Autoleucel). 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 R/R MM. IASO also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) from the FDA in February 2022, Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations from the FDA in February 2023. In addition to multiple myeloma, NMPA has approved IND application of FUCASO® for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Additionally, the company's in-house developed fully human CD19/CD22 dual-targeted CAR-T cell therapy 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). It is currently in Phase I clinical trial for r/r B-NHL. It was also granted ODD for treatment of acute lymphoblastic leukemia by the FDA in October 2021. And the fully human monoclonal antibody targeting human CD19, IASO-782 Injection, received both FDA and NMPA IND approvals in June 2023 for use in U.S. and China clinical trials for Autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA). 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 as well as around the world. For more information, visit or . About Innovent Biologics 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 9 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), Retsevmo® (selpercatinib) and FUCASO® (Equecabtagene Autoleucel). An additional 2 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. Contact: IASO Bio Media: [email protected] Investors: [email protected] Innovent Biologics Media: [email protected]com +86 512-6956 6088 Investors: [email protected]com +86 512-6956 6088 SOURCE IASO Bio

SHANGHAI and NANJING, China and SAN JOSE , CA, USA I June 5, 2023 I I ASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, and Innovent Biologics, Inc. ("Innovent," HKEX: 01801), today jointly announced the updated data from phase 1b/2 study of Equecabtagene Autoleucel (IASO Bio R&D code: CT103A, Innovent R&D code: IBI326), 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 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 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 1.0×10 6 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 response, 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 (MM) is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For MM 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 new cancer cases and more than 2% of all cancer-related deaths. According to Frost & Sullivan, new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and are expected to increase to 37,800 by 2025. Additionally, the 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, new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and are expected to increase to 24,500 by 2025. The 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 strict selection and screening, utilizing a proprietary in-house optimization platform, and integrated in-house manufacturing process improvement, the construct of Equecabtagene Autoleucel is potent and shows prolonged persistency in patients. 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). IASO Bio and Innovent are jointly developing Equecabtagene Autoleucel for the treatment of RRMM 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 . About Innovent Biologics 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. SOURCE: IASO Biotechnology

ROCKVILLE, Md. and SUZHOU, China, June 5, 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 or . 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. SOURCE Innovent Biologics