Core Insights - The article discusses the phenomenon of "middlemen profiting" in the innovative drug industry, highlighted by the strategic collaboration between BMS and BNT, which involved a $9 billion deal for the drug BNT327, originally licensed from Chinese company Pumice Biotech [1][2] - The rapid increase in valuations and the perceived undervaluation of Chinese biotech firms are emphasized, with examples illustrating how companies like Pumice and Hengrui have faced challenges in capturing the full value of their innovations [1][2][3] Summary by Sections Strategic Collaborations - BMS and BNT's partnership to develop BNT327 is valued at $9 billion, with Pumice Biotech originally licensing the drug for $55 million [1] - Hengrui Pharmaceuticals licensed its asthma drug SHR-1905 to Aiolos Bio for $25 million upfront, which was later sold to GSK for $10 billion, showcasing the significant markup in valuations [2] Market Dynamics - The article highlights the immature valuation system for innovative drug companies in China and their limited international operational capabilities, leading to unfavorable deals [2][3] - The quality of clinical data and the lack of unique assets hinder Chinese companies' bargaining power in the global market [3] Evolution of BD Transactions - The evolution of business development (BD) transactions in China is outlined, with three phases: exploration (pre-2014), development (2015-2019), and explosion (2020-present) [4][5] - The surge in BD transactions is attributed to the establishment of numerous innovative drug companies post-2010 and regulatory changes that encouraged innovation [5][6] License-in and License-out Trends - License-in transactions dominated initially, allowing companies to mitigate risks and shorten development timelines, but led to inflated prices and market bubbles [6][7] - License-out transactions have recently surpassed License-in, indicating a shift in strategy as companies seek immediate cash flow amid financial pressures [8] New Business Models - The emergence of the NewCo model allows companies to retain longer-term control over their product pipelines while attracting investment, marking a shift from traditional licensing agreements [13][14] - The NewCo model has gained traction among various biotech firms, enabling them to better manage their assets and secure funding [13][15] Future Outlook - The article concludes that while "cheap sales" of assets may continue, Chinese biotech firms are increasingly integrating into the global ecosystem, necessitating a focus on maximizing value within the international value chain [15][16]

Core Viewpoint - The innovative drug sector is experiencing a significant surge in stock prices, driven by positive news and market momentum, with both A-shares and Hong Kong stocks showing substantial gains in related companies [1][2][3]. Group 1: Market Performance - On July 17, A-shares saw a collective rise, with the Shanghai Composite Index up by 0.37%, the Shenzhen Component up by 1.43%, and the ChiNext Index up by 1.76% [1]. - The innovative drug sector led the market, with nearly 20 related stocks hitting the daily limit or rising over 10%, including Chengdu XianDai, Saily Medical, and Lisheng Pharmaceutical [1][3]. Group 2: Positive News and Developments - A recent report indicated that the innovative drug "Qiruisuo Wei," developed in China for treating respiratory syncytial virus, has been included in the World Health Organization's priority list for children's medications, potentially providing accessible and affordable treatment for children globally [4][5][6]. - The WHO's initiative aims to accelerate the development of urgently needed children's medications, highlighting the critical need for effective treatments for respiratory syncytial virus, which causes millions of infections and significant mortality among young children each year [5]. Group 3: Policy Support - The National Healthcare Security Administration and the National Health Commission have issued measures to support the high-quality development of innovative drugs, including increasing support for R&D, facilitating access to insurance coverage, and enhancing clinical application [8]. - The introduction of a commercial health insurance directory for innovative drugs marks a significant step in expanding the role of commercial insurance in the multi-tiered healthcare system, providing more opportunities for high-priced innovative drugs [9][10]. Group 4: Industry Outlook - Analysts predict that the domestic innovative drug industry may reach a turning point in 2025, shifting from capital-driven growth to profit-driven growth, presenting opportunities for both performance and valuation recovery [11]. - China's share in global innovative drug business development transactions is expected to increase significantly, with a notable rise in the number and value of projects, particularly in areas like ADC and bispecific antibodies [12].

Core Viewpoint - The rise of innovative drug themes is driven by a combination of policy, technology, and capital, marking a significant transition in China's pharmaceutical industry from generics to innovation [1] Historical Context of Innovative Drugs - Before 2015, China's pharmaceutical industry was dominated by generics, with long drug approval cycles (averaging 3-5 years) and low R&D investment (less than 5% of revenue) [2] - Key players like Hengrui Medicine and BeiGene began to focus on innovative drug development, with Hengrui launching the first domestic PD-1 inhibitor in 2014 [3] Current Landscape and Policy Support - By 2025, the National Medical Products Administration (NMPA) aims to significantly reduce clinical trial review times from 60 days to 30 days, with pilot projects averaging only 23.8 working days [5] - In the first half of 2025, 43 innovative drugs were approved, with over 90% being domestic products, particularly in oncology [5] - New policies in Beijing allow for direct hospital admission of innovative drugs without the need for a drug committee meeting, enhancing access [5] Technological Advancements and Internationalization - Chinese pharmaceutical companies are increasingly competitive globally, with significant advancements in areas like ADC and bispecific antibodies [5] - In the first half of 2025, over 70 overseas licensing transactions were recorded, with total transaction amounts reaching $48 billion, including a record $1.25 billion upfront payment for a PD-1/VEGF bispecific collaboration [6] Market Dynamics and Investment Trends - The innovative drug sector is expected to enter a three-year upward cycle driven by frequent major business development (BD) transactions and improving profitability for leading companies [7] - The innovative drug index in Hong Kong has seen a year-to-date increase of over 34%, reflecting strong market recognition of long-term value [9] Key Players and Financial Performance - Hengrui Medicine, with a market cap of approximately 379.78 billion yuan, leads in R&D investment and has a robust pipeline, including a PD-1 inhibitor with cumulative sales exceeding 20 billion yuan [10] - BeiGene, with a market cap of around 369.47 billion yuan, has achieved significant international sales, with its drug Zanubrutinib generating over 8 billion yuan in global sales in the first half of 2024 [11] Emerging Trends and Future Outlook - The integration of AI in drug development is expected to enhance efficiency, with projections indicating the AI pharmaceutical market could exceed $3 billion by 2030 [16] - The innovative drug market in China is anticipated to reach approximately 2.3 trillion yuan by 2030, with a compound annual growth rate of 24.1% [16]

Core Viewpoint - The article discusses the promising potential of CLDN18.2 as a therapeutic target for gastric and gastroesophageal junction adenocarcinoma, highlighting the development and clinical trial results of the antibody-drug conjugate (ADC) IBI343 [1][4][9]. Group 1: IBI343 Overview - IBI343 is an ADC developed by Innovent Biologics, consisting of a fully humanized anti-CLDN18.2 monoclonal antibody, a DNA topoisomerase I (TOP-1) inhibitor, and a cleavable linker, with a drug-to-antibody ratio of 4 [2]. - The clinical trial results published in Nature Medicine indicate that IBI343 shows good tolerability and manageable safety, with a low incidence of gastrointestinal adverse events in patients with high CLDN18.2 expression [3][4]. Group 2: Clinical Trial Results - A total of 127 patients with advanced gastric or gastroesophageal junction adenocarcinoma were enrolled in the phase 1 trial, with 19 in the dose escalation phase and 108 in the dose expansion phase [7]. - At a dose of 10 mg/kg, 2 out of 6 participants experienced dose-limiting toxicities, including one case of grade 4 bone marrow suppression and one case of grade 4 neutropenia [8]. - The recommended phase 2 dose is 6 mg/kg every 3 weeks, showing an objective response rate of 29% and a median progression-free survival of 5.5 months in patients with high CLDN18.2 expression [9]. Group 3: Future Research Directions - Ongoing phase 3 multicenter, randomized, controlled studies and future research on the combination of IBI343 with other therapies, particularly immunotherapies, may provide further evidence supporting IBI343 as a new treatment option for gastric and gastroesophageal junction adenocarcinoma and other CLDN18.2-expressing solid tumors [10][11].

Group 1 - Hong Kong biopharmaceutical stocks experienced an initial surge, with 康方生物 (09926.HK) rising over 8% [1] - 泰格医药 (03347.HK) increased by more than 4% [1] - 百济神州 (06160.HK) and 复宏汉霖 (02696.HK) both saw nearly 4% gains [1] - 金斯瑞生物科技 (01548.HK) rose by over 3% [1]

特此公告。 百济神州有限公司董事会 A股代码：688235 A股简称：百济神州 公告编号：2025-027 港股代码：06160 港股简称：百济神州 美股代码：ONC 百济神州有限公司 自愿披露关于公司举行业绩电话会议的公告 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。 百济神州有限公司（以下简称"公司"）将于美国东部时间 2025 年 8 月 6 日（星期三）发布根据美国公认会计原则及美国证券交易委员 会适用规则编制的截至 2025 年 6 月 30 日止第二季度未经审计财务业绩 并同步发布根据中国企业会计准则编制的 2025 年半年度主要财务数据 公告。 公司管理团队将于美国东部时间 2025 年 8 月 6 日（星期三）上午 8 时（即北京时间 2025 年 8 月 6 日（星期三）晚上 8 时）举行业绩电话 会议。业绩电话会议将进行网络直播，可通过公司网站投资者关系页面 进 入 ， 网 址 为 https://ir.beonemedicines.com 、 https://sseir.beonemedicine ...

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，並明確表示概不就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。 BeOne Medicines Ltd. 百濟神州有限公司 （根據瑞士法律註冊成立的公司） （股份代號：06160） 相关ETF 百濟神州有限公司（「本公司」）謹此公佈，本公司將於2025年8月6日（星期三） （即 香港聯交所交易時間之後）報告其根據美國公認會計原則及美國證券交易委員會 適用規則編製的截至2025年6月30日止第二季度的未經審核財務業績。本公司董 事會審計委員會將於2025年8月6日（香港時間）審閱及批准2025年第二季度的財 務業績。 財務業績發佈後，本公司將於美國東部時間2025 年8 月6 日（星期三）上午八時正 （即香港時間2025年8月6日（星期三）下午八時正）舉行電話會議。 電話會議將以網路直播方式進行，網絡直播鏈接可從本公司網站的投資者關係頁 面訪問，網址為 https://ir.beonemedicines.com , https://hkexir.beonemedicin ...

Group 1 - The National Medical Products Administration (NMPA) has accepted the marketing application for Baiyue Shenzhou's Talatuzumab injection, which is intended for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least second-line treatment [1] - Talatuzumab is a first-in-class DLL3/CD3 bispecific antibody that may bring breakthrough advancements in the treatment of SCLC, a type of lung cancer with a high rate of incidence and mortality [1][2] - SCLC accounts for approximately 15% of all lung cancer cases, with about 70% of patients diagnosed at the extensive stage, leading to a median overall survival (mOS) of only 4 to 5 months after initial treatment [1] Group 2 - DLL3 protein is considered a highly attractive therapeutic target in SCLC, with up to 96% of SCLC patients expressing this protein [2] - Talatuzumab utilizes an innovative T-cell engaging (BiTE) structure, which allows for effective targeting of tumor cells and T-cells, potentially making it a novel therapy for SCLC [2] - Interim analysis from a global Phase 3 clinical trial presented at the 2025 American Society of Clinical Oncology annual meeting showed that Talatuzumab treatment resulted in a median overall survival of 13.6 months, significantly extending survival by 5.3 months compared to standard chemotherapy [2]

百濟神州有限公司（「本公司」）謹此公佈，本公司將於2025年8月6日（星期三）（即 香港聯交所交易時間之後）報告其根據美國公認會計原則及美國證券交易委員會 適用規則編製的截至2025年6月30日止第二季度的未經審核財務業績。本公司董 事會審計委員會將於2025年8月6日（香港時間）審閱及批准2025年第二季度的財 務業績。 財務業績發佈後，本公司將於美國東部時間2025年8月6日（星期三）上午八時正 （即香港時間2025年8月6日（星期三）下午八時正）舉行電話會議。 電話會議將以網路直播方式進行，網絡直播鏈接可從本公司網站的投資者關係頁 面訪問，網址為 https://ir.beonemedicines.com , https://hkexir.beonemedicines.com , https://sseir.beonemedicines.com 。為確保及時連接，建議與會者在預定的網絡直 播前至少15分鐘進行註冊。本公司網站將提供業績電話會議網絡直播的存檔回 放。 本公司另將於2025年8月29日或之前公佈其根據香港聯合交易所有限公司證券上 市規則（「香港上市規則」）編製的截至2025年6月30日止六個 ...

A股代码：688235 A股简称：百济神州 公告编号：2025-027 港股代码：06160 港股简称：百济神州 美股代码：ONC 百济神州有限公司 自愿披露关于公司举行业绩电话会议的公告 1 2025 年 7 月 17 日 2 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。 百济神州有限公司（以下简称"公司"）将于美国东部时间 2025 年 8 月 6 日（星期三）发布根据美国公认会计原则及美国证券交易委员 会适用规则编制的截至 2025 年 6 月 30 日止第二季度未经审计财务业绩 并同步发布根据中国企业会计准则编制的 2025 年半年度主要财务数据 公告。 公司管理团队将于美国东部时间 2025 年 8 月 6 日（星期三）上午 8 时（即北京时间 2025 年 8 月 6 日（星期三）晚上 8 时）举行业绩电话 会议。业绩电话会议将进行网络直播，可通过公司网站投资者关系页面 进 入 ， 网 址 为 https://ir.beonemedicines.com 、 https://sseir.beonemedici ...