Core Viewpoint - Zai Ding Pharmaceutical (09688) shares rose over 5%, currently up 5.38% at HKD 25.48, with a trading volume of HKD 224 million [1] Group 1: Clinical Research Updates - Recently, Zai Ding Pharmaceutical announced that its partner Amgen has completed the final analysis of the FORTITUDE-101 Phase III clinical study, which evaluates the efficacy of Bemarituzumab combined with chemotherapy (mFOLFOX6) for first-line treatment of gastric cancer [1] - The interim analysis showed significant statistical and clinical improvement in overall survival with the Bemarituzumab combination compared to chemotherapy alone; however, the survival benefit observed in the interim analysis weakened in the final analysis [1] - Amgen stated that the results of both the interim and final analyses will be presented at an upcoming major medical conference [1] Group 2: Future Research Plans - Based on the updated results from the FORTITUDE-101 study, the company plans to wait for the results of the FORTITUDE-102 study, which aims to evaluate Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be released by the end of 2025 or in the first half of 2026 [1]

Core Viewpoint - Zai Ding Pharma (09688) shares rose over 5%, reaching HKD 25.48 with a trading volume of HKD 224 million following the announcement of the final analysis of the FORTITUDE-101 Phase III clinical trial for Bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment [1] Group 1: Clinical Trial Results - The FORTITUDE-101 trial showed significant statistical and clinical improvement in overall survival when comparing Bemarituzumab combined with chemotherapy to chemotherapy alone during the pre-set interim analysis [1] - However, the final analysis indicated a reduction in the previously observed survival benefit [1] - Amgen, the partner and sponsor of the study, plans to present the results of both the interim and final analyses at an upcoming major medical conference [1] Group 2: Future Plans - The company intends to wait for the results of the FORTITUDE-102 study, which evaluates Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Core Insights - The final analysis of the FORTITUDE-101 Phase III clinical study for bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment has been completed, showing a reduction in previously observed survival benefits compared to the interim analysis [1] Group 1: Clinical Study Results - The interim analysis indicated significant statistical and clinical improvement in overall survival for the bemarituzumab plus chemotherapy compared to chemotherapy alone [1] - The final analysis revealed a weakening of the survival benefit previously observed in the interim analysis [1] Group 2: Future Plans - The company plans to wait for the results of the FORTITUDE-102 study, which evaluates bemarituzumab combined with nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Group 1 - The core point of the article is that the final analysis of the FORTITUDE-101 Phase III clinical study for bemarituzumab combined with chemotherapy (mFOLFOX6) in first-line gastric cancer treatment shows a reduction in previously observed survival benefits compared to the interim analysis [1] - The interim analysis indicated a statistically and clinically significant improvement in overall survival for the bemarituzumab combination therapy compared to chemotherapy alone [1] - The results from both the interim and final analyses will be presented at an upcoming major medical conference [1] Group 2 - The company plans to wait for the results of the FORTITUDE-102 study, which aims to evaluate bemarituzumab combined with nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

Core Viewpoint - The final analysis of the FORTITUDE-101 Phase III clinical study for Bemarituzumab combined with mFOLFOX6 in first-line gastric cancer treatment shows a reduction in previously observed survival benefits compared to the interim analysis [1] Group 1: Clinical Study Results - The interim analysis indicated significant statistical and clinical improvement in overall survival for the combination therapy compared to chemotherapy alone [1] - The final analysis revealed a weakening of the survival benefit previously observed in the interim analysis [1] Group 2: Future Plans - The company plans to wait for the results of the FORTITUDE-102 study, which evaluates Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be available by the end of 2025 or the first half of 2026 [1]

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，概不會對因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 根據 FORTITUDE-101 研究的更新結果，本公司計劃在提交註冊申請之前等待 FORTITUDE-102 研究（其旨在評估貝瑪妥珠單抗聯合納武利尤單抗及化療用於相同的 患者人群）的結果。預計 FORTITUDE-102 研究的數據將在 2025 年底或 2026 年上半年 公佈。 承董事會命 再鼎醫藥有限公司 Zai Lab Limited 再鼎醫藥有限公司* （於開曼群島註冊成立的有限公司） （股份代號：9688） 內幕消息 安進貝瑪妥珠單抗 FORTITUDE-101 III 期臨床研究最新進展 本公告乃由再鼎醫藥有限公司（「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)條及香港法例第 571 章證券及期貨條例第 XIVA 部 項下內幕消息條文（定義見上市規則）而作出。 據安進公司，本公司的合作夥伴和該項研究的申辦方，評估貝瑪妥珠單抗聯合化療 （ ...

Core Viewpoint - The article discusses the introduction of the commercial insurance innovative drug directory in China, which supplements the basic medical insurance directory and aims to include high-priced innovative drugs that provide significant clinical value and patient benefits [2][10]. Summary by Sections Introduction of the Commercial Insurance Innovative Drug Directory - The National Healthcare Security Administration announced a list of drugs that passed the initial review for the commercial insurance innovative drug directory, with a total of 121 drugs, over half of which are cancer or rare disease medications [2][5]. - The directory is expected to include high-priced drugs, such as CAR-T therapies costing over 1 million yuan per injection and gene therapies priced around 98,000 yuan per injection [2][4]. Drug Approval and Characteristics - To qualify for the commercial insurance innovative drug directory, drugs must either be newly approved from January 1, 2020, to June 30, 2025, or have indications included in the national rare disease directory by June 30, 2025 [5]. - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer and Johnson & Johnson [5]. Focus on Cancer and Rare Diseases - The majority of drugs that passed the initial review are cancer treatments, with over 40 entries, followed by 35 for rare diseases [5][6]. - The article highlights the potential for the directory to alleviate payment challenges for rare disease medications, with companies actively submitting applications [6]. Pricing and Negotiation Challenges - The pricing negotiation process for drugs in the commercial insurance directory remains uncertain, as it involves collaboration between the National Healthcare Security Administration, commercial insurers, and pharmaceutical companies [12][13]. - The article notes that the commercial insurance directory may serve as a "double insurance" for companies, allowing them to apply for both the basic medical insurance and the commercial insurance directories simultaneously [9]. Future Considerations and Recommendations - The article suggests that the implementation of the commercial insurance innovative drug directory requires further exploration and refinement, with recommendations for pilot programs in specific insurance products [14]. - It emphasizes the need for insurance companies to develop reasonable pricing mechanisms and improve data integration with basic medical insurance to enhance their pricing strategies [13][14].

Core Insights - The National Healthcare Security Administration (NHSA) has released a list of drugs that passed the preliminary review for the commercial insurance innovative drug directory, which is a new supplement to the basic medical insurance directory aimed at covering high-priced drugs [2][3] - A total of 121 drugs have passed the initial review, with over half being cancer or rare disease medications, including several high-cost therapies [2][5] - The final commercial insurance innovative drug directory is expected to be published between October and November 2023, following expert evaluations and price negotiations [2][3] Summary by Category Drug Characteristics - The drugs included in the commercial insurance innovative drug directory are characterized by high innovation, significant clinical value, and substantial patient benefits, exceeding the basic insurance's "basic protection" scope [2] - Among the 121 drugs, 57 are imported, accounting for 47%, with notable entries from companies like Pfizer, Johnson & Johnson, and Merck [5] Pricing and Negotiation - The drugs will undergo price negotiations, which may lead to price reductions, but the extent of these reductions remains uncertain [9][10] - The commercial insurance innovative drug directory allows for simultaneous applications to both the basic medical insurance and the commercial insurance directories, providing a "double insurance" for companies [7] Market Dynamics - The directory includes a variety of drugs, including CAR-T therapies priced around 1 million yuan per injection, which have faced challenges in entering the basic medical insurance directory [6][9] - The directory's implementation may alleviate payment difficulties for rare disease medications, with companies actively submitting applications [6][8] Insurance Industry Considerations - The insurance industry faces challenges in pricing and market growth potential due to the voluntary nature of commercial insurance participation [9][11] - There is a need for better data integration between commercial insurance and basic medical insurance to enhance pricing strategies and product development [11]

Core Viewpoint - Immune checkpoint inhibitors (ICIs) have transformed the treatment of various solid tumors, but resistance remains a significant challenge, particularly in advanced and recurrent ovarian cancer, where response rates to single-agent PD-1/PD-L1 inhibitors are only 5%-15% [2][3] Group 1: Research Findings - A study published in Nature by a team from MD Anderson Cancer Center found that patients with PPP2R1A gene mutations had significantly improved survival after receiving combined anti-PD-1/PD-L1 and anti-CTLA-4 immunotherapy compared to those with wild-type PPP2R1A [3][6] - The presence of PPP2R1A mutations enhances tumor response to immunotherapy, and this finding was validated across various cancer types in clinical cohorts [3][9] - In recurrent ovarian cancer, dual targeting of PD-1/PD-L1 and CTLA-4 showed a response rate of 31.4% compared to 12.2% for single-agent PD-1 therapy, indicating a potential benefit for patients with ovarian clear cell carcinoma (OCCC) [5][6] Group 2: Clinical Implications - The study suggests that targeting PPP2R1A could represent an effective strategy to improve outcomes for cancer patients undergoing immunotherapy [9] - Enhanced immune cell infiltration and signaling pathways were observed in tumors with PPP2R1A mutations, indicating a more favorable immune environment for treatment [8] - The research team is conducting prospective trials to explore the efficacy of dual immune checkpoint blockade in OCCC patients, particularly those with platinum-resistant disease [5][6]

Investment Rating - The report indicates a positive investment rating for the innovative drug sector, particularly highlighting the success of the combination therapy of Bemesumab and Anlotinib in treating NSCLC [8][11]. Core Insights - The report emphasizes the significant progress in the treatment of non-small cell lung cancer (NSCLC) through innovative therapies, particularly the combination of immune checkpoint inhibitors and anti-angiogenic agents, which have shown improved progression-free survival (PFS) rates compared to traditional therapies [7][11]. - The CAMPASS trial demonstrated that the combination of Bemesumab and Anlotinib significantly extended the median PFS to 11.0 months compared to 7.1 months for the control group, marking a notable advancement in first-line treatment options for PD-L1 positive advanced NSCLC [11]. - The report also discusses the ongoing clinical trials and the potential for new drug approvals, indicating a robust pipeline for innovative therapies in the oncology sector [12][47]. Summary by Sections Section 1: Focus on Innovative Drugs - The report reviews the latest developments in innovative drugs, particularly in the context of NSCLC treatments and highlights the importance of combination therapies [2][3]. Section 2: Clinical Trial Results - The report details the results of the CAMPASS trial, which compared the efficacy of Bemesumab combined with Anlotinib against Pembrolizumab in treating advanced NSCLC, showcasing a significant improvement in PFS [11][12]. - It also covers the mid-term analysis of the TQB2450-III-12 trial, which further supports the efficacy of the Bemesumab and Anlotinib combination in squamous NSCLC [13]. Section 3: Market Developments - The report notes the recent approvals and submissions for new drug indications, reflecting a dynamic and rapidly evolving market for innovative cancer therapies [45][49]. - It highlights the performance of various biotech companies in the market, indicating significant fluctuations in stock prices and market capitalization [41][43].