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]

每经AI快讯，9月8日，截至发稿，复宏汉霖(02696.HK)涨7.76%、药明康德(02359.HK)涨4.40%、药明生 物(02269.HK)涨4.11%、再鼎医药(09688.HK)涨3.64%。 （文章来源：每日经济新闻） ...

Core Viewpoint - Zai Lab Limited is under investigation for potential securities fraud following the release of disappointing final results from a Phase 3 clinical trial for its drug bemarituzumab, leading to a significant drop in its stock price [1][3]. Group 1: Company Overview - Zai Lab Limited is a biopharmaceutical company listed on NASDAQ under the ticker ZLAB [1]. - The company is currently facing claims of securities fraud or unlawful business practices, prompting an investigation by Pomerantz LLP [1]. Group 2: Clinical Trial Results - On September 3, 2025, Zai Lab announced the completion of the final analysis of the Phase 3 FORTITUDE-101 trial for bemarituzumab in combination with chemotherapy for first-line gastric cancer [3]. - The interim analysis had shown a significant improvement in overall survival compared to chemotherapy alone, but the final analysis indicated that this survival advantage had diminished [3]. - Zai Lab plans to await results from the FORTITUDE-102 trial before proceeding with regulatory filing, with data readout expected by the end of 2025 or the first half of 2026 [3]. Group 3: Market Reaction - Following the announcement of the final trial results, Zai Lab's American Depositary Receipt (ADR) price fell by $2.04, or 6.12%, closing at $31.30 per ADR on September 3, 2025 [3].

Summary of Zai Lab (ZLAB) 2025 Conference Call Company Overview - Zai Lab has been operational for ten years, focusing on two main business segments: a robust commercial business in China and a global clinical pipeline [3][4] Key Business Segments 1. **Commercial Business in China** - Partnerships with Western biotechs to develop and commercialize products in China - Portfolio includes over 10 products, with Zejula and Vivgard expected to drive profitability by Q4 2025 [4] - Anticipated sales growth from Vivgard, targeting approximately $1 billion in annual sales by 2028, up from $94 million last year [7][8] 2. **Global Pipeline** - Lead asset is a DLL3 targeted ADC for small cell lung cancer, with a registration trial expected to start imminently [5] - Potential for sales in the US as early as late 2027 [5] Financial Projections - Zai Lab aims to achieve $2 billion in sales by 2028, a significant increase from approximately $560 million projected for this year [6][7] - Growth drivers include: - Vivgard for myasthenia gravis, expected to trend towards $500 million by 2028 [9] - Cobemfi for schizophrenia, with potential for billion-dollar sales [11] - Zejula for ovarian cancer, expected to contribute significantly through patent protection until 2029 [12] Market Dynamics - The myasthenia gravis market in China has about 180,000 patients, with Zai Lab aiming to increase patient exposure to Vivgard significantly [8] - New treatment guidelines in China have positioned Vivgard as a frontline therapy, which is expected to enhance patient adoption and sales [30][31] Regulatory and Competitive Landscape - Zai Lab is involved in the bemiratuzumab program for gastric cancer, with recent data indicating a potential delay in submission due to updated survival benefit analysis [19][24] - The company is preparing for a competitive landscape in small cell lung cancer, with plans to start a registration trial for DLL3 ADC [58] Pricing Strategy - Zai Lab is approaching a two-year price renegotiation for Vivgard, expecting a single-digit price reduction based on simplified renewal processes [42][44] - Anticipated pricing adjustments will be disclosed in December, with net pricing effective from January 2026 [47] Conclusion - Zai Lab is positioned for significant growth driven by a strong product pipeline and strategic partnerships, with a focus on expanding its market presence in China and the US. The company is optimistic about achieving its sales targets while navigating regulatory challenges and competitive pressures in the biotech industry [6][24][58]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 公司名稱: 再鼎醫藥有限公司 呈交日期: 2025年9月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09688 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.000006 USD | | 30,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.000006 USD | | 30,000 | 本月底法定/註冊股本總額： USD 30,000 FF301 第 1 頁 共 11 頁 v ...

Core Viewpoint - The Hong Kong Innovative Drug ETF (159567) experienced a decline of 3.38% on September 4, with a trading volume of 1.427 billion yuan. The fund has shown significant growth in both share volume and total assets since its inception in January 2024 [1][2]. Group 1: Fund Performance - The Hong Kong Innovative Drug ETF (159567) was established on January 3, 2024, with a management fee of 0.50% and a custody fee of 0.10% [1]. - As of September 3, 2024, the fund's latest share volume was 6.668 billion shares, and its total assets reached 6.724 billion yuan. This represents an increase of 1586.48% in share volume and 1679.83% in total assets compared to December 31, 2023, when the share volume was 395 million shares and total assets were 378 million yuan [1]. Group 2: Trading Activity - Over the past 20 trading days, the cumulative trading amount for the Hong Kong Innovative Drug ETF (159567) was 33.138 billion yuan, with an average daily trading amount of 1.657 billion yuan. Since the beginning of the year, the cumulative trading amount over 165 trading days was 185.061 billion yuan, averaging 1.122 billion yuan per day [1]. Group 3: Fund Holdings - The current fund manager of the Hong Kong Innovative Drug ETF (159567) is Ma Jun, who has managed the fund since its inception, achieving a return of 99.52% during this period [2]. - Key holdings in the fund include: - Innovent Biologics (9.52% holding, 2.60 billion yuan market value) - WuXi Biologics (9.47% holding, 2.58 billion yuan market value) - BeiGene (8.73% holding, 2.38 billion yuan market value) - CanSino Biologics (7.62% holding, 2.08 billion yuan market value) - China National Pharmaceutical Group (7.17% holding, 1.96 billion yuan market value) - CSPC Pharmaceutical Group (6.34% holding, 1.73 billion yuan market value) - 3SBio (5.83% holding, 1.59 billion yuan market value) - Hansoh Pharmaceutical (4.54% holding, 1.24 billion yuan market value) - Zai Lab (2.86% holding, 781.055 million yuan market value) [2].

Market Overview - The A-share market experienced a significant adjustment on September 4, with major indices declining, including the Shanghai Composite Index dropping over 2% and the ChiNext Index falling by more than 3.8% [4][3] - The STAR 50 Index saw a sharp decline, with intraday losses exceeding 5% [4][3] Sector Performance - The telecommunications sector faced heavy losses, with a decline of over 8%, impacting several previously high-performing stocks [5] - Notable stocks such as Xinyi Communications and Zhongji Xuchuang experienced intraday drops exceeding 14% [7] - The electronics sector also suffered, with a decline of over 4%, and leading stock Cambrian Technology saw a drop of over 13% [7] New Energy Sector - In contrast, the new energy sector showed resilience, with the CSI New Energy Theme Index rising nearly 4% at one point [11] - Key stocks in this sector, such as EVE Energy, saw intraday gains exceeding 13%, while Zhongwei Co. and Shanneng Electric experienced gains of over 14% and 16%, respectively [14] Financial Performance of Key Companies - EVE Energy reported a revenue of 28.17 billion yuan for the first half of 2025, marking a year-on-year increase of 30.06%, with a net profit attributable to shareholders of 1.605 billion yuan [14]

Group 1 - The core viewpoint of the article highlights a collective decline in Hong Kong's innovative drug concept stocks on September 4, with significant drops in various companies [1] Group 2 - Zai Lab experienced a decline of over 10% [1] - Hengrui Medicine, Genscript Biotech, and Cloudmed fell by more than 5% [1] - WuXi AppTec dropped over 4%, while Innovent Biologics, WuXi Biologics, and Hansoh Pharmaceutical decreased by more than 3% [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]