iza-bren凭借优异的临床研究成果，解决了后线食管鳞癌有效疗法急缺的空白。其此次获受理的适应 症，精准聚焦于"既往经PD-1/PD-L1单抗联合含铂化疗治疗失败的复发性或转移性食管鳞癌"，旨在为这 类患者提供全新的治疗选择。这款全球首创的新药，一旦在中国获批，意味着中国患者将有望领先海外 约三年，率先获益于此创新治疗方案。 近日，国家药品监督管理局药品审评中心(CDE)官网公示信息显示，由百利天恒(02615)自主研发、全球 首创(First-in-class)、新概念(New concept)且唯一完成关键性注册研究的EGFR x HER3双抗ADC药物iza- bren一项新增适应症上市许可申请(NDA)成功获得国家药品监督管理局(NMPA)受理。该适应症用于治 疗既往经PD-1/PD-L1单抗联合含铂化疗治疗失败的复发性或转移性食管鳞癌，为该类难治性肿瘤患者 带来新的治疗希望。 此前，iza-bren在食管鳞癌的III期临床试验(研究方案编号：BL-B01D1-305)中，经独立数据监查委员会 (iDMC)判断，在预设的期中分析中达到无进展生存期(PFS)和总生存期(OS)双主要终点。本次NDA受理 ...

iza-bren凭借优异的临床研究成果，解决了后线食管鳞癌有效疗法急缺的空白。其此次获受理的适应 症，精准聚焦于"既往经PD-1/PD-L1单抗联合含铂化疗治疗失败的复发性或转移性食管鳞癌"，旨在为这 类患者提供全新的治疗选择。这款全球首创的新药，一旦在中国获批，意味着中国患者将有望领先海外 约三年，率先获益于此创新治疗方案。 此外，iza-bren也已在晚期食管鳞癌的早期临床试验中展现优异数据，并在国际权威学术期刊Nature Medicine上发布。在82例ESCC患者中，iza-bren治疗晚期食管鳞癌早期临床研究中表现出抗肿瘤活性以 及可管理的安全性。 作为百利天恒创新管线的核心重磅产品，iza-bren的研究和临床价值备受全球监管机构认可。截至目 前，iza-bren已在中国和美国已开展40余项针对10余种肿瘤类型的临床试验，其中，于美国正在开展3项 用于三阴性乳腺癌、EGFR突变非小细胞肺癌和尿路上皮癌的II/III期注册临床试验，以及于中国正在开 展11项用于不同适应症治疗的III期临床试验，并获得CDE的7项突破性疗法认定、美国食品药品监督管 理局(FDA)的1项突破性疗法认定，彰显其在全球肿 ...

Core Viewpoint - The global offering of Bailitianheng (02615.HK) has been delayed due to current market conditions, and the company will not proceed with the initial public offering as planned [1] Group 1: Offering Details - Bailitianheng's public offering was initially scheduled from November 7 to 12, with a listing date of November 17 [1] - The company announced that the international underwriting agreement will not be established, and the public offering underwriting agreement will not become unconditional [1] - As of today, the estimated margin for Bailitianheng is approximately HKD 6.33 billion, with the public portion raising HKD 336 million, resulting in an oversubscription of about 17.8 times [1] Group 2: Business Impact - The decision to delay the global offering does not affect the company's current business operations, and the company remains committed to developing and expanding its business [1] - The company and its overall coordinators are carefully evaluating the updated timeline for the global offering and listing [1]

四川百利天恒藥業股份有限公司 香港交易及結算所有限公司、香港聯合交易所有限公司（「聯交所」）及香港中央結算有限公司 （「香港結算」）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 示概不會就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。 本公告僅作說明用途，並不構成任何人士收購、購買或認購證券的要約或要約邀請。有意投資 者於決定是否投資發售股份前應細閱四川百利天恒藥業股份有限公司（「本公司」）刊發的日期為 2025年11月7日的招股章程（「招股章程」）及本公司將予刊發的任何補充招股章程內有關香港公 開發售及國際發售的詳細資料。除文義另有所指外，本公告所用詞彙與招股章程所界定者具有 相同涵義。 本公告不會直接或間接於或向美國（包括美國的領土及屬地、美國任何州以及哥倫比亞特區） 發佈、刊發或派發。本公告並不構成亦不屬於在美國境內或於任何其他司法權區購買或認購證 券的任何要約或招攬的一部分。發售股份並無亦不會根據《1933年美國證券法》（經修訂）（「美 國證券法」）或美國任何州或其他司法權區的證券法登記。證券不得在美國境內提呈發出售、質 押或以其他方式轉讓，惟獲 ...

Core Viewpoint - The Hong Kong Stock Exchange welcomes another "A+H" biopharmaceutical company, Baillie Tianheng, which has launched its IPO with a price range of HKD 347.50 to HKD 389.00, despite facing significant financial challenges and a lack of sustainable revenue sources [2][4]. Financial Performance - In 2024, Baillie Tianheng is projected to generate revenue of CNY 58.23 billion and a net profit of CNY 37.08 billion, largely due to an $800 million upfront payment from a partnership with Bristol-Myers Squibb (BMS) [2]. - However, in the first half of 2025, the company's revenue is expected to plummet to CNY 1.71 billion, a staggering decline of 96.92% year-on-year, with a net loss of CNY 11.18 billion [2]. - The company's R&D expenses reached CNY 10.39 billion in the first half of 2025, a 90.74% increase, amounting to approximately six times its revenue during the same period [2]. Product Pipeline - Baillie Tianheng's core product, iza-bren, is the world's first EGFR×HER3 dual-targeted ADC drug and the only one in Phase III clinical development, with a total licensing agreement worth up to $8.4 billion with BMS [4]. - Clinical data presented at the 2025 European Society for Medical Oncology meeting showed an overall objective response rate of 55% in patients with advanced heavily pre-treated solid tumors, indicating its potential as a broad-spectrum drug [5]. - Another promising drug, T-Bren, demonstrated an objective response rate of 82.2% in HER2-positive breast cancer patients, with a median progression-free survival of 18 months, showcasing better therapeutic potential compared to its competitor [6]. Market Dynamics - The IPO has attracted five cornerstone investors, including BMS and Athos Capital, who collectively subscribed to approximately HKD 248 million worth of shares, representing 7.8% of the offering [7]. - The absence of a greenshoe option in the IPO raises concerns about price stability post-listing, especially given the recent underperformance of A+H shares in the biopharmaceutical sector [8]. - The high entry cost of HKD 39,292.31 for retail investors may deter participation, suggesting a cautious approach for those less familiar with the biopharmaceutical industry [8].

Core Viewpoint - The recent IPO of BaiLi Tianheng in the Hong Kong market is expected to fill a gap in the ADC drug sector, driven by technological advancements, surging demand, and supportive policies [1][2]. Group 1: IPO Details - BaiLi Tianheng plans to launch its H-share global public offering with a base issuance of 8,634,300 shares, including 863,500 shares for public sale in Hong Kong [1]. - The price range for the shares is set between 347.50 HKD and 389.00 HKD, with trading expected to commence on November 17 [1]. - The H-shares are eligible for inclusion in the Stock Connect program on the listing date [1]. Group 2: Strategic Partnerships and Market Position - The IPO has attracted significant interest from major investors, including Goldman Sachs, JPMorgan, and notable cornerstone investors like Bristol-Myers Squibb (BMS) [2][3]. - BaiLi Tianheng's strong market position is attributed to its robust ADC drug development, independent global clinical capabilities, and innovative commercialization strategies [2]. - The partnership with BMS involves a groundbreaking deal worth 8.4 billion USD for the ADC product Iza-bren, marking a significant milestone in the ADC sector [3][4]. Group 3: Product Development and Clinical Trials - Iza-bren is the first-in-class dual-target ADC drug, currently in Phase III clinical trials, showing promising efficacy with a 55% overall response rate in late-stage cancer patients [5][6]. - The drug's potential peak sales could exceed 20 billion USD, indicating a strong commercial outlook [5][6]. - BaiLi Tianheng is also advancing another ADC, T-Bren, which has shown superior efficacy and safety compared to competitors, with a clinical objective response rate of 82.2% [7][8]. Group 4: Financial Strength and Future Prospects - As of June 30, BaiLi Tianheng had over 5 billion CNY in cash reserves, bolstered by a recent 3.764 billion CNY A-share placement and potential future payments from BMS [12]. - The company is positioned for significant growth in the global market, with a focus on building a comprehensive R&D and commercialization framework [10][11]. - The overall market sentiment towards innovative biopharmaceuticals is improving, with BaiLi Tianheng expected to be a key player in the sector [13].

Major Events - LeShuShi (02698) received a subscription rate of 1813.77 times for its public offering in Hong Kong, with an expected listing date of November 10 [1] - Zhongwei New Materials (02579) is in the process of an IPO from November 7 to November 12, with an expected listing on November 17 [1] - Baili Tianheng (02615) is also conducting an IPO from November 7 to November 12, with a listing expected on November 17 [1] - Haohai Biological Technology (06826) plans to acquire the remaining 20% stake in Shenzhen New Industry Ophthalmic Technology Co., Ltd. for 74 million yuan [1] - Weili Zhibo-B (09887) has been included in the MSCI Global Small Cap Index [1] - Heng Rui Medicine (01276) has received clinical trial approval notifications for HRS-2430 injection and SHR-4610 injection [1] Financial Data - Fuzhikang Group (02038) anticipates a year-on-year revenue growth of approximately 15% and significant improvement in financial performance [1] - Boya Interactive (00434) expects a year-on-year increase of approximately 105% to 115% in profit attributable to owners for the first nine months [1] - Longfor Group (00960) reported a total contract sales amount of 55.75 billion yuan for the first ten months [1] - Longyuan Power (00916) completed a total power generation of 62.1519 million megawatt-hours in the first ten months, representing a year-on-year decrease of 0.94% [1]

Investment Rating - The report suggests a cautious subscription for the company [2]. Core Insights - The company is engaged in innovative drug research and development, manufacturing, and sales, with a focus on a unique EGFR×HER3 bispecific antibody ADC that is currently in Phase III clinical development [2]. - The company has established a robust ADC drug development platform, successfully advancing 10 candidate drugs into clinical stages and conducting approximately 70 clinical studies [2][3]. - The global ADC market is projected to grow significantly, reaching USD 13.5 billion in 2024 and USD 150.2 billion by 2033, with notable growth expected in both the Chinese and U.S. markets [3]. - The company's revenue is expected to show substantial growth, with a forecasted increase from HKD 701.8 million in 2022 to HKD 5.8 billion in 2024, representing a year-on-year growth of 1,033% [3]. - The company reported a loss of HKD 289.1 million in 2022, which increased to HKD 769.0 million in 2023, but is projected to turn profitable in 2024 with earnings of HKD 3.98 billion [3]. Summary by Sections IPO Details - The company plans to raise HKD 3.017 billion through its IPO, with a share price range of HKD 347.5 to HKD 389 [1]. - The total number of shares available for subscription is 8.63 million, with 90% allocated for international placement and 10% for public offering [1]. Financial Performance - The company’s revenue is projected to grow significantly from HKD 701.8 million in 2022 to HKD 5.8 billion in 2024, with a 40% year-on-year increase in the first half of 2025 [3]. - The company is expected to turn profitable in 2024 after reporting losses in previous years [3].

Core Viewpoint - The company, 百利天恒 (02615), is set to launch an initial public offering (IPO) from November 7 to November 12, 2025, with a global offering of 8.6343 million shares priced between HKD 347.5 and HKD 389 per share, aiming to raise approximately HKD 3.018 billion in net proceeds [1][4]. Group 1: Business Overview - The company operates as a comprehensive medical enterprise with capabilities in early research, clinical development, production, and commercialization, focusing on two main business segments: innovative biopharmaceuticals and generic medicines, including traditional Chinese medicine [1]. - The company has developed a strong expertise in the fields of generic and traditional Chinese medicines since 1996, with a product portfolio covering anesthesia, parenteral nutrition, anti-infection, and pediatrics [3]. Group 2: Research and Development Achievements - Over the past decade, the company has established a research and development platform for innovative antibody-drug conjugates (ADCs), successfully developing 10 ADC candidates that have entered clinical stages, including the globally unique izabren (BL-B01D1) [2]. - The company has also developed a multi-specific T-cell engager platform, resulting in four GNC innovative multi-specific antibody drug candidates that have entered clinical stages, along with an innovative ARC drug development platform [2]. Group 3: Financial and Investment Details - The company has secured cornerstone investment agreements with several investors, including BMS and others, agreeing to subscribe for shares totaling approximately USD 32 million or about HKD 249 million, subject to certain conditions [3]. - The estimated net proceeds from the global offering, based on a median indicative offer price of HKD 368.25 per share, will be allocated as follows: approximately 60% for R&D of biopharmaceutical candidates outside mainland China, 30% for establishing a global supply chain, and 10% for operational funds and general corporate purposes [4].

Core Viewpoint - Bailitianheng (02615) has announced the launch of its H-share global public offering and plans to list on the Hong Kong Stock Exchange, marking a significant addition to the biotech sector in Hong Kong [1]. Group 1: H-share Offering Details - The base number of shares for the global offering is set at 8,634,300 shares, with 863,500 shares (approximately 10%) allocated for public offering in Hong Kong and 7,770,800 shares (approximately 90%) for international offering [1]. - The initial price range for the shares is determined to be between HKD 347.50 and HKD 389.00 [1]. - Bailitianheng's H-shares are expected to be eligible for inclusion in the Stock Connect program on the listing date [1]. Group 2: Company Overview - Bailitianheng focuses on cutting-edge biopharmaceuticals, addressing unmet clinical needs, particularly in the field of tumor macromolecule therapy, and aims to achieve global commercialization capabilities by 2029 [2]. - The company has established R&D centers in the U.S. and China, responsible for early product development and subsequent clinical research [2]. - Bailitianheng has developed a leading innovative drug R&D platform with global rights and complete intellectual property, including the HIRE-ADC platform and GNC platform [2]. Group 3: Clinical Development and Pipeline - The company has successfully developed three Phase III clinical assets (two ADC drugs and one bispecific antibody) and 14 early-stage core clinical assets [2]. - Bailitianheng is conducting nearly 90 clinical trials globally, including 15 Phase III studies in China and 10 in the U.S. [2]. Group 4: Strategic Collaborations and Financials - Bailitianheng has entered a strategic partnership with Bristol-Myers Squibb (BMS), involving an upfront payment of USD 800 million and a potential total deal value of up to USD 8.4 billion [4]. - The company has received the upfront payment and anticipates additional payments based on the success of ongoing clinical trials [4].