CM 355

BEIJING--(BUSINESS WIRE)-- Data of InnoCare's (HKEX: 09969; SSE: 688428) robust pipelines were presented at the European Hematology Association (EHA) 2024 Hybrid Congress. 1. Subcutaneous ICP-B02 (CM355), a Novel Bispecific CD20/CD3 Antibody Showed Promising Efficacy and Favorable Safety Pro Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (Abstract No.: P2097) This study aimed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK)/ pharmacodynamics (PD) of ICP-B02 in relapsed/refractory (R/R) B-cell non-hodgkin lymphoma (NHL). At the doses evaluated, ICP-B02 subcutaneously (SC) demonstrated favorable safety pro promising efficacy in patients with R/R B-cell NHL. All Cytokine release syndrome (CRS) events were manageable with minimal intervention. Rapid and deep responses, as well as the convenience of SC formulation, support further clinical development for treatment of B cell NHL. Efficacy results showed that the overall response rate (ORR) was 100.0% with complete response rate (CRR) was 77.8%. 2. Preliminary Safety and Efficacy Data from Patients with Relapsed or Refractory B-Cell Malignancies Treated with ICP-248, a Novel BCL2 Inhibitor (Abstract No.: P1851) This study aimed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ICP-248 in patients with relapsed or refractory B-cell malignancies. Preliminary results of ICP-248 monotherapy suggest well tolerated safety pro promising efficacy with dose-dependent effect in relapsed or refractory B-cell malignancies. The ORR was 100% at 100 mg dose level, with three patients achieved complete response. Further assessment of safety and efficacy with additional dose levels and dosing strategies will be pursued in expanded patient population and in the combination with Orelabrutinib. 3. A Phase II, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract No.: P2091) Relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) remains a high unmet medical need, especially in patients who are ineligible for autologous stem cell transplant (ASCT). The study demonstrates that tafasitamab plus lenalidomide regimen is well tolerated in Chinese population with good efficacy, and the efficacy and safety data are consistent with the L-MIND study. As of the data by Jan. 29, 2024, the ORR assessed by IRC was 73.1%, with 32.7% of patients achieving CR and 40.4% of patients with partial response (PR). The ORR assessed by investigators was 69.2%, with 34.6% of patients reaching CR and 34.6% of patients achieved PR. 4. Orelabrutinib-Lenalidomide-Rituximab in Patients with Untreated Mantle Cell Lymphoma (MCL): Updated Results of the Multicenter, Phase II Polaris Study (Abstract No.: P1141) This study aimed to explore whether orelabrutinib combined with rituximab plus lenalidomide would exhibit synergistic antitumor activity in mantle cell lymphoma (MCL) and improve the depth and durability of response. The data confirmed the potent antitumor activity and manageable safety of the orelabrutinib-lenalidomide-rituximab regimen in patients with untreated MCL. Detection of peripheral blood (PB) ctDNA detection based on NGS could contribute to predicting prognosis. Of response-evaluable patients who had completed 6 cycles of induction therapy, 67.9% achieved CR and 17.9% achieved PR, with an ORR of 85.8%. Median duration of response (DOR) and median progress-free survival (PFS) were not reached. 5. Orient Study: Orelabrutinib Addition to R-Chop-Like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL (Abstract No.: P1167) This is a multicenter, open-label phase II study, aiming to assess efficacy and safety of orelabrutinib plus R-CHOP-like regimen for untreated non-GCB DLBCL patients who respond to induction therapy of orelabrutinib plus rituximab. Primary endpoint was complete remission rate (CRR) after 6-cycle orelabrutinib plus R-Chop-like regimen. All the patients who completed 6-cycle therapy attained CR at the end of cycle 6. Although preliminary, responders to orelabrutinib plus rituximab induction may further benefit from subsequent orelabrutinib plus R-Chop-like regimen, achieving high CRR and sustaining CR throughout post-therapy follow-up; no unexpected safety issue occurred. 6. The Primary Results of R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) as the First-Line Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: P1193) This study aimed to investigate the efficacy and safety of rituximab, methotrexate, thiotepa, and orelabrutinib regimen followed by autologous hematopoietic stem cell transplantation (ASCT) in treatment of the patients with PCNSL. The rituximab, methotrexate, thiotepa, and orelabrutinib regimen induction treatment has demonstrated notable efficacy in achieving higher response rates among patients with newly diagnosed PCNSL, and a tolerable safety profile. 7. Orelabrutinib in Patients with Indolent Non-Hodgkin Lymphoma (INHL) Intolerant to Prior Bruton Tyrosine Kinase Inhibitors (BTKI): Preliminary Results from a Phase 2 Study (Abstract No.: P2074) This study aimed to assess the safety and activity of orelabrutinib in prior BTKi-intolerant iNHL. Orelabrutinib improved outcomes of prior BTKi-intolerant AEs, particularly the off-target toxicities (cardiac/infectious AEs). The preliminary result of this study showed promising efficacy and safety data of orelabrutinib in prior BTKi-intolerant iNHL patients. 8. Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (CWCLL-001 Study) (Abstract No.: P680) This study was initiated to evaluate the efficacy and safety of orelabrutinib plus fludarabine, cyclophosphamide and obinutuzumab in younger, fit patients with previously untreated CLL/SLL without restriction by del(17p)/TP53 aberrations and/or IGHV mutation status. The regimen leads to a rapid and deep molecular remission with a manageable safety pro previously untreated CLL patients including those with unfavorable characteristics. 9. Different Subtype of DLBCL Patients Treated with R-Chop (Like) Plus Orelabrutinib Regimen: A Real-World Study (Abstract No.: PB3034) This retrospective study aimed to compare the efficacy and safety of R-CHOP-like regimen combined with orelabrutinib in patients with different subtypes of DLBCL. The study demonstrated that patients with double-expression and extranodal involvement benefit from orelabrutinib and that earlier addition of orelabrutinib results in a higher proportion of complete remissions, and more detailed analyses comparing the benefits in different types of patients are underway. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. InnoCare Forward-looking Statements This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. View source version on businesswire.com: Contacts Media Chunhua Lu 86-10-66609879 chunhua.lu@innocarepharma.com Investors 86-10-66609999 ir@innocarepharma.com Source: InnoCare Pharma View this news release online at:

2024年5月27日，中国北京——生物医药高科技公司诺诚健华（上交所代码：688428；香港联交所代码：09969）今日宣布，公司相关管线的14项研究入选2024年欧洲血液学协会（EHA）年会，涉及公司多款不同机制重要靶点的创新药，包括BTK抑制剂奥布替尼、CD20xCD3双抗ICP-B02（CM355）、BCL2抑制剂ICP-248和CD19单抗坦昔妥单抗（tafasitamab），展现了诺诚健华在血液瘤领域的创新实力。作为血液学领域顶级学术会议之一，2024年欧洲血液学协会（EHA）年会于2024年6月13日至16日在西班牙马德里召开。以下是入选研究：1. Preliminary Safety and Efficacy Data from Patients with Relapsed or Refractory B-Cell Malignancies Treated with ICP-248, a Novel BCL2 Inhibitor (Abstract No.: 4207)新型BCL2抑制剂ICP-248治疗复发或难治性B细胞恶性肿瘤患者的初步安全性和有效性数据（摘要代码：4207）2. A Phase II, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract No.: 5124)一项评估坦昔妥单抗联合来那度胺治疗复发/难治性弥漫性大B细胞淋巴瘤患者的安全性和有效性的II期单臂开放标签研究（摘要代码：5124）3. Subcutaneous ICP-B02 (CM355), a Novel Bispecific CD20/CD3 Antibody Showed Promising Efficacy and Favorable Safety Profile in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (Abstract No.: P2097)新型CD20/CD3双特异性抗体ICP-B02（CM355）（皮下注射）在复发/难治性B细胞非霍奇金淋巴瘤中展现良好的疗效和安全性（摘要代码：P2097）4. Orelabrutinib-Lenalidomide-Rituximab in Patients with Untreated Mantle Cell Lymphoma (MCL): Updated Results of the Multicenter, Phase II Polaris Study (Abstract No.: P1141)POLARIS研究：奥布替尼联合来那度胺和利妥昔单抗治疗初治MCL的多中心II期研究数据随访更新（摘要代码：P1141）5. Orient Study: Orelabrutinib Addition to R-Chop-Like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL (Abstract No.: P1167)ORIENT研究：基于奥布替尼联合利妥昔单抗应答适应性导向的方案治疗初治non-GCB弥漫大B细胞淋巴瘤的前瞻性II期临床研究（摘要代码：P1167）6. The Primary Results of R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) as the First-Line Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: P1193)（利妥昔单抗、甲氨蝶呤、塞替派和奥布替尼）一线使用R-MTO方案诱导治疗后自体干细胞移植治疗新诊断的原发性中枢神经系统淋巴瘤的初步结果（摘要代码：P1193）7. Orelabrutinib in Combination with PD-1 Inhibitor Inrefractory or Relapsed Primary CNS Lymphoma (Abstract No.: P1194)奥布替尼联合PD-1抑制剂治疗复发/难治性原发性中枢神经系统淋巴瘤（摘要代码：P1194）8. Real-World Outcomes of Orelabrutinib as First-Line Treatment in CLL/SLL: A Multicenter Study (Abstract No.: P1855)奥布替尼一线治疗CLL/SLL的真实世界结果：一项多中心研究（摘要代码：P1855）9. Orelabrutinib in Patients with Indolent Non-Hodgkin Lymphoma (INHL) Intolerant to Prior Bruton Tyrosine Kinase Inhibitors (BTKI): Preliminary Results from a Phase 2 Study (Abstract No.: P2074)奥布替尼单药治疗既往BTK 抑制剂不耐受的经治B细胞恶性肿瘤的一项前瞻性、多中心、开放、单臂临床研究（摘要代码：P2074）10. Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic  Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (CWCLL-001 Study) (Abstract No.: P680)奥布替尼联合氟达拉滨、环磷酰胺以及奥妥珠单抗（OFCG）一线治疗CLL：一项多中心、研究者发起的研究（CWCLL-001 研究）（摘要代码：P680）11. Real-World Analysis of Orelabrutinib in Patients (PTS) with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (Abstract No.: PB2562)奥布替尼治疗慢性淋巴细胞白血病(cll)/小淋巴细胞淋巴瘤(sll)患者的回顾性真实世界分析（摘要代码：PB2562）12. Phase II Study of Orelabrutinib, Rituximab and Thiotepa (ORT) Combined with or without High-Dose MTX Therapy in Patients with Primary CNS Lymphoma (Abstract No.: PB2964)奥布替尼、利妥昔单抗、塞替派（ORT）联合或不联合大剂量甲氨蝶呤（HD-MTX)治疗原发中枢神经系统淋巴瘤的II 期临床研究（摘要代码：PB2964）13. Different Subtype of DLBCL Patients Treated with R-Chop (Like) Plus Orelabrutinib Regimen: A Real-World Study (Abstract No.: PB3034)奥布替尼联合R-CHOP-like方案治疗不同亚型DLBCL的真实世界研究（摘要代码：PB3034）14. Orelabrutinib, Rituximab and High-Dose Methotrexate (HD-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL): A Retrospective Analysis on Efficacy and Safety (Abstract No.: PB3036)奥布替尼、利妥昔单抗联合大剂量甲氨蝶呤（HD-MTX）在新诊断的原发性中枢神经系统淋巴瘤（PCNSL）中的疗效和安全性：一项回顾性分析（摘要代码：PB3036）关于诺诚健华诺诚健华（上交所代码：688428；香港联交所代码：09969）是一家商业化阶段的生物医药高科技公司，专注于恶性肿瘤及自身免疫性疾病领域的一类新药研制。公司现有多个新药产品处于商业化、临床及临床前研发阶段。公司在北京、南京、上海、广州、香港以及美国设有分支机构。