Core Viewpoint - The company, Innovent Biologics (688428.SH), has received approval from the National Medical Products Administration (NMPA) for its self-developed next-generation TRK inhibitor, Zolbetuximab (ICP-723), making it the first domestically developed next-generation TRK inhibitor approved for marketing in China [1] Group 1: Product Approval - Zolbetuximab is approved for the treatment of adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] Group 2: Clinical Trial Results - In the pivotal registration clinical trial for patients with NTRK fusion-positive solid tumors, Zolbetuximab demonstrated excellent efficacy and safety as a broad-spectrum anti-cancer drug [1] - The overall response rate (ORR) was 89.1%, and the disease control rate (DCR) was 96.4% [1] - The 24-month progression-free survival (PFS) rate was 77.4%, and the 24-month overall survival (OS) rate was 90.8% [1]

Core Insights - The National Medical Products Administration (NMPA) has approved the second-generation small molecule pan-TRK inhibitor, Zoltracitinib (ICP-723), for the treatment of adult and adolescent patients (aged 12 and above) with solid tumors carrying NTRK fusion genes [1] - Zoltracitinib demonstrated exceptional efficacy with an objective response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8% in clinical trials [1] - The drug is part of the "Starlight Program," aimed at encouraging the development of pediatric oncology drugs, with plans to submit a new drug application (NDA) for treating pediatric patients (aged 2 to 12) soon [1] Company Insights - Zoltracitinib is positioned as a next-generation TRK inhibitor, offering improved efficacy over first-generation TRK inhibitors, with strong brain penetration and overall safety [1] - The oral administration of Zoltracitinib, taken once daily in two tablets, provides significant convenience for patients [1] Industry Insights - NTRK fusion genes have been identified in over 26 types of solid tumors, with an estimated 6,500 new cases of tumors carrying NTRK fusion genes diagnosed annually in China [2] - Patients with NTRK fusion-positive tumors typically have a short survival period, rapid disease progression, and high disability rates, indicating an unmet clinical need due to the low prevalence of next-generation sequencing (NGS) for diagnosis [2]

Core Viewpoint - The company, Innovent Biologics, has received approval from the National Medical Products Administration (NMPA) for its self-developed next-generation TRK inhibitor, Zolbetuximab (ICP-723), making it the first domestically developed next-generation TRK inhibitor approved for marketing in China [1] Group 1 - The new drug is indicated for the treatment of adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] - In key registration clinical trials for patients with NTRK fusion-positive solid tumors, Zolbetuximab demonstrated excellent efficacy and safety as a broad-spectrum anti-cancer drug [1] Group 2 - The registration clinical study results showed an overall response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4% [1] - The 24-month progression-free survival (PFS) rate was 77.4%, and the 24-month overall survival (OS) rate was 90.8% [1]

Core Viewpoint - The approval of the second-generation TRK inhibitor, Zoltracitinib (ICP-723), by the National Medical Products Administration (NMPA) marks a significant advancement in the treatment of adult and adolescent patients with NTRK fusion gene-positive solid tumors, showcasing high efficacy and safety [1][2]. Group 1: Company Developments - Zoltracitinib has demonstrated an objective response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4% in clinical trials for NTRK fusion-positive solid tumors [1]. - The 24-month progression-free survival (PFS) rate is reported at 77.4%, while the overall survival (OS) rate stands at 90.8% [1]. - The drug is included in the "Starlight Program," aimed at encouraging the development of pediatric oncology drugs, with plans to submit a new drug application (NDA) for treating children aged 2 to 12 years soon [1]. Group 2: Industry Context - NTRK fusion genes have been identified in over 26 types of solid tumors, with an estimated 6,500 new cases in China each year [2]. - Patients with NTRK fusion-positive tumors typically experience short survival, rapid disease progression, and high disability rates, highlighting an unmet clinical need due to delays in diagnosis from low prevalence of next-generation sequencing (NGS) [2].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 內幕消息公告 批准佐來曲替尼在中國用於治療攜帶NTRK融合基因的 成人和青少年實體瘤患者 本公告乃由諾誠健華醫藥有限公司（「本公司」）根據香港聯合交易所有限公司 證券上市規則（「上市規則」）第13.09(2)(a)條及證券及期貨條例（香港法例第571章） 第XIVA部項下之內幕消息條文（定義見上市規則）而作出。 本公司董事會（「董事會」）欣然宣佈，國家藥品監督管理局(NMPA)已批准第二 代小分子泛原肌球蛋白相關激酶抑制劑（泛TRK抑制劑）佐來曲替尼(ICP-723)， 用於治療攜帶NTRK融合基因的成人和12歲以上青少年實體瘤患者。 在針對NTRK融合陽性的實體瘤患者的註冊臨床試驗中，佐來曲替尼展示出卓 越的有效性和良好的安全性。研究結果顯示客觀 ...

Core Viewpoint - The company, Innovent Biologics, announced that its self-developed next-generation TRK inhibitor, Zolbetuximab (ICP-723), has received approval from the National Medical Products Administration of China, marking it as the first domestically developed next-generation TRK inhibitor approved for marketing in China [1] Group 1 - The new drug is intended for the treatment of adult and adolescent patients aged 12 and older with solid tumors carrying NTRK fusion genes [1]

| 股代码：688428 A | 股简称：诺诚健华 A | 公告编号：2025-039 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于佐来曲替尼（ICP-723）在中国 上市申请获得批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 NTRK 融合基因存在于各种类型的肿瘤，目前已在超过 26 种实体瘤中发现 了 NTRK 融合基因。中国每年新发的携带 NTRK 融合基因的肿瘤人群预估 6,500 例，这些患者生存期短、疾病进展快、致残率高，而由于目前金标准检测方法— —下一代测序（NGS）的普及率较低，导致诊断延迟，因此仍存在未被满足的临 床需求。广谱抗癌药佐来曲替尼的出现，为患者带来了新的治疗选择。 在针对 NTRK 融合阳性的实体瘤患者的关键注册临床试验中，佐来曲替尼 作为不限瘤种的广谱抗癌药展示了卓越的有效性和安全性。注册临床研究结果显 示总缓解率（ORR）达 89.1%，疾病控制率（DCR）为 96.4%，24 个月无进展生 ...

Core Viewpoint - The biopharmaceutical company, Nuo Cheng Jian Hua, announced the presentation of over 20 research data on its novel BTK inhibitor, Oubatinib, at the 67th American Society of Hematology (ASH) annual meeting, showcasing its efficacy and safety across various lymphoma studies. Group 1: Efficacy and Safety Data - Oubatinib demonstrated a total response rate (ORR) of 89.5% and a complete response rate (CRR) of 78.9% after six treatment cycles, with a median time to response of 2.6 months and a 2-year duration of response (DoR) of 72.4% [2] - In a study involving newly diagnosed primary central nervous system lymphoma (PCNSL), Oubatinib combined with rituximab and high-dose methotrexate showed superior predictive and prognostic value compared to PET-CT, with early clearance of ctDNA and MYD88 [1] - The combination of Oubatinib and Obinutuzumab for initial treatment of marginal zone lymphoma (MZL) showed an ORR of 96.0% and a CRR of 72.0% in 27 evaluable patients, with 100% ORR in 10 patients completing six cycles [3] - Oubatinib combined with rituximab in treatment-naïve MZL patients showed an ORR of 81.8% and a CRR of 72.7%, indicating promising efficacy despite small sample size [4] - Oubatinib combined with bendamustine-rituximab demonstrated favorable tumor response and survival outcomes compared to bendamustine-rituximab alone in high-risk mantle cell lymphoma (MCL) patients [5] Group 2: Real-World Studies and Future Research - A large-scale real-world study provided insights into treatment patterns and outcomes for different genetic subtypes of diffuse large B-cell lymphoma (DLBCL) in China, showing enhanced efficacy of R-CHOP plus BTK inhibitors in MCD-like subtype patients [6] - In the MCD-like treatment group, the CRR for R-CHOP combined with Oubatinib was 81.4% [7] - A prospective study indicated that the combination of pomalidomide, rituximab, and Oubatinib is a potential treatment option for elderly or frail DLBCL patients, achieving a 100% ORR in patients completing three cycles [7] - Oubatinib monotherapy for chronic lymphocytic leukemia (CLL) patients showed a 100% ORR and disease control rate (DCR) in both first-line and subsequent treatments [8] - Additional studies on Oubatinib are set to be presented at the 2025 ASH annual meeting, covering various combinations and treatment strategies for different lymphoma types [8]

Core Insights - InnoCare Pharma presented over 20 studies on its BTK inhibitor orelabrutinib at the 67th Annual Meeting of the American Society of Hematology (ASH) [1] Efficacy and Safety - Orelabrutinib has shown significant efficacy and safety across multiple lymphoma types, including marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), primary central nervous system lymphoma (PCNSL), and diffuse large B-cell lymphoma (DLBCL) [2] - In a study involving newly diagnosed PCNSL, the combination of orelabrutinib, rituximab, and high-dose methotrexate achieved an objective response rate (ORR) of 89.5% and a complete response (CR) rate of 78.9% [4] - The orelabrutinib and obinutuzumab combination demonstrated an ORR of 96.0% in treatment-naïve MZL patients, with no severe toxicities reported [6][5] - Orelabrutinib combined with rituximab showed an ORR of 81.8% and a CR rate of 72.7% in treatment-naïve MZL patients who were unsuitable for local therapy [7][8] - The orelabrutinib plus bendamustine-rituximab regimen showed promising tumor response and survival outcomes in transplant-ineligible, intermediate- to high-risk MCL patients [9] Real-World Studies - A large-scale real-world study in China indicated that R-CHOP plus orelabrutinib achieved a CR rate of 81.4% in MCD-like DLBCL patients, supporting subtype-directed therapy [11] - Preliminary results from a phase II study suggest that the PRO-Pola regimen is a potential treatment option for elderly, unfit, or frail DLBCL patients, with a CRR of 77.8% and an ORR of 100% among those completing three cycles [12][13] - A retrospective real-world study indicated that orelabrutinib monotherapy achieved an ORR and disease control rate (DCR) of 100% in CLL patients [14] Future Directions - Additional studies on orelabrutinib have been selected for poster presentation and publication at the 2025 ASH Annual Meeting, indicating ongoing research and development efforts [15]

Core Viewpoint - InnoCare Pharma has presented over 20 studies on its BTK inhibitor orelabrutinib at the 67th Annual Meeting of the American Society of Hematology, highlighting its efficacy and safety in treating various lymphomas and chronic lymphocytic leukemia [1][2]. Group 1: Efficacy and Safety of Orelabrutinib - Orelabrutinib has shown significant efficacy in multiple lymphoma types, including marginal zone lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, primary central nervous system lymphoma, and diffuse large B-cell lymphoma [2]. - In a study involving newly diagnosed primary central nervous system lymphoma, the combination of orelabrutinib, rituximab, and high-dose methotrexate achieved an objective response rate (ORR) of 89.5% and a complete response (CR) rate of 78.9% [4]. - The orelabrutinib and obinutuzumab combination demonstrated an ORR of 96.0% in treatment-naïve marginal zone lymphoma patients, with no severe toxicities reported [5][6]. Group 2: Treatment Outcomes and Comparisons - The orelabrutinib plus bendamustine-rituximab regimen showed promising tumor response and survival outcomes compared to the standard bendamustine-rituximab regimen in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma [9]. - In a large-scale real-world study of diffuse large B-cell lymphoma in China, the R-CHOP regimen combined with orelabrutinib achieved a CR rate of 81.4% in MCD-like patients, supporting subtype-directed therapy [11]. - A prospective phase II study indicated that the combination of pomalidomide, rituximab, and orelabrutinib is a potential treatment option for elderly, unfit, or frail patients with diffuse large B-cell lymphoma, achieving a CR rate of 77.8% among those who completed three cycles [12][13][14]. Group 3: Future Research and Development - Additional studies on orelabrutinib have been selected for poster presentation and publication at the 2025 ASH Annual Meeting, indicating ongoing research and development efforts [15]. - InnoCare is committed to discovering and commercializing innovative drugs for cancer and autoimmune diseases, with a focus on addressing unmet medical needs [17].