Core Viewpoint - InnoCare Pharma's next-generation TRK inhibitor, zurletrectinib, has received approval from the China National Medical Products Administration for treating adult and adolescent patients with solid tumors harboring NTRK gene fusions, marking a significant advancement in cancer treatment options in China [1][4]. Group 1: Efficacy and Safety - In clinical trials, zurletrectinib demonstrated an objective response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4%, with 24-month progression-free survival (PFS) and overall survival (OS) rates of 77.4% and 90.8% respectively [2]. - The drug shows superior efficacy compared to first-generation TRK inhibitors, achieving a 100% ORR in adolescent patients and demonstrating a long duration of response exceeding 36 months in some cases [3][4]. - Zurletrectinib exhibits strong brain penetration activity, achieving an intracranial objective response rate (IC-ORR) of 100% in lung cancer patients, providing new treatment options for those with brain metastases [4]. Group 2: Clinical Importance and Future Prospects - The approval of zurletrectinib is significant for patients with NTRK fusion-positive solid tumors, addressing a critical need for effective treatments in a patient population with limited options [4][6]. - InnoCare plans to submit a new drug application for zurletrectinib to treat pediatric patients aged 2 to 12, indicating a commitment to expanding treatment options for younger patients [4][5]. Group 3: Market Context - NTRK fusion genes are present in over 26 types of tumors, with approximately 6,500 new cases occurring annually in China, highlighting the unmet clinical needs in this area [5]. - The low adoption rate of next-generation sequencing (NGS) for diagnosis contributes to delayed treatment, emphasizing the importance of zurletrectinib in improving patient outcomes [5].

Core Viewpoint - The approval of Zolbetuximab (ICP-723) as the first domestically developed next-generation TRK inhibitor in China represents a significant advancement in treatment options for adult and adolescent patients with NTRK fusion gene-positive solid tumors [1][2] Group 1: Product Approval - The National Medical Products Administration (NMPA) has granted approval for Zolbetuximab (宜诺欣®), making it the first next-generation TRK inhibitor approved in China [1] - The drug is specifically indicated for adult and adolescent patients aged 12 and above with solid tumors carrying NTRK fusion genes [1] Group 2: Clinical Need - NTRK fusion genes are found in over 26 types of solid tumors, with an estimated 6,500 new cases in China each year [1] - Patients with NTRK fusion-positive tumors typically have a short survival period, rapid disease progression, and high disability rates, highlighting an unmet clinical need due to delayed diagnosis from low prevalence of next-generation sequencing (NGS) [1] Group 3: Clinical Trial Results - In pivotal registration trials, Zolbetuximab demonstrated an overall response rate (ORR) of 89.1% and a disease control rate (DCR) of 96.4% [2] - The 24-month progression-free survival (PFS) rate was 77.4%, and the overall survival (OS) rate was 90.8% [2] - Zolbetuximab shows superior efficacy compared to first-generation TRK inhibitors, with strong brain penetration and good overall safety [2] Group 4: Administration and Convenience - The drug is administered orally once daily, with a dosage of two tablets per administration, providing significant convenience for patients [2]

Core Viewpoint - The company, Innovent Biologics (688428.SH), has received approval from the National Medical Products Administration for its self-developed next-generation TRK inhibitor, Zolbetuximab (宜诺欣®, ICP-723), making it 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] - The development of new drugs is characterized by high technology, high risk, and high added value, with long and complex cycles from research and clinical studies to production [1] - The drug development process is susceptible to uncertainties, which may impact investment decisions [1]

Core Insights - NMPA has approved the second-generation small molecule TRK inhibitor, Zoltracitinib (ICP-723), for treating adult and adolescent patients (12 years and older) with NTRK fusion gene-positive solid tumors [1] Group 1: Drug Efficacy and Safety - Zoltracitinib demonstrated exceptional efficacy with 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 77.4%, and the overall survival (OS) rate is 90.8% [1] - As a next-generation TRK inhibitor, Zoltracitinib shows improved efficacy over first-generation TRK inhibitors, with strong brain penetration and good overall safety [1] Group 2: Administration and Convenience - Zoltracitinib is administered orally once daily at a dosage of two tablets, providing significant convenience for patients [1] Group 3: Market Potential and Clinical Need - NTRK fusion genes have been identified in over 26 types of solid tumors, with an estimated 6,500 new cases carrying NTRK fusion genes in China each year [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 low prevalence of next-generation sequencing (NGS) for diagnosis [2] Group 4: Future Developments - The company plans to submit a new drug application (NDA) for Zoltracitinib to treat pediatric patients (ages 2 to 12) soon, as it has been included in the "Starlight Program" aimed at encouraging the development of pediatric oncology drugs [1]

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]