格隆汇10月22日丨热景生物(688068.SH)公布，公司收到参股公司舜景医药关于自主研制的创新药 SGC001 注射液 Ib 期临床研究获得了积极的初步结果的汇报。 舜景医药开展的创新药 SGC001 注射液分别在健康志愿者中和在前壁ST段抬高型心肌梗死患者中开展 了 2 个 I 期研究。截至本公告披露日，SGC001 注射液已完成 Ib 期临床试验并取得《一项评估 SGC001 在中国前壁ST 段抬高型心肌梗死且计划接受经皮冠状动脉介入治疗的患者中的安全性、耐受性、药代 动力学特征、免疫原性和初步疗效的随机、双盲、安慰剂对照、单次给药剂量递增的Ib期临床研究统计 分析表格》。 SGC001 是一款由舜景医药孙志伟教授研发团队联合首都医科大学北京市心肺血管疾病研究所杜杰教 授、李玉琳教授团队共同开发研制的急救用单克隆抗体药物，适用于急性心肌梗死（Acute Myocardial Infarction, AMI）(首先开展的适应症为"前壁 ST 段抬高型心肌梗死")患者的急救治疗。此前，针对AMI 疾病，暂无相关抗体药物进入临床研究阶段及审批上市。截至本公告日，SGC001 临床试验申请 （IND）已先后获 ...

Core Insights - The article discusses the increasing trend of innovative pharmaceutical companies going public in the Hong Kong market to secure funding, highlighting the importance of cash flow for sustaining operations and research and development [4][5][6] - It emphasizes the need for a diversified financing approach, combining business development (BD) collaborations and IPOs to create a "safety net" for innovation [6][10] - The article also examines the financial challenges faced by specific companies, such as Wangshan Wangshui and Ying'en Biotechnology, detailing their revenue fluctuations and strategic responses to market competition [10][15] Group 1: Market Trends - In 2023, 21 innovative pharmaceutical companies have listed on the Hong Kong Stock Exchange, with notable first-day performances, such as Silver诺医药's 206% increase [4] - The Hong Kong market continues to expand, with companies like Wangshan Wangshui preparing for IPOs, raising questions about their ability to replicate previous successes [4][5] Group 2: Wangshan Wangshui's Financial Performance - Wangshan Wangshui's revenue is projected to drop from 200 million yuan to 11.83 million yuan in 2023-2024, a decline of over 94% [10] - The company reported a profit of 6.427 million yuan in 2023 but is expected to incur a loss of 218 million yuan in 2024 [10][11] - The decline in revenue is attributed to a significant drop in licensing income, particularly from its collaboration with Junshi Biosciences on the COVID-19 treatment VV116 [11][12] Group 3: Wangshan Wangshui's Product Pipeline - Wangshan Wangshui is attempting to expand the indications for VV116 to include respiratory syncytial virus (RSV) treatment, but faces competition from faster-moving rivals [12][13] - The company has two additional core products targeting depression and erectile dysfunction, but both are entering highly competitive markets [13][14] Group 4: Ying'en Biotechnology's Strategy - Ying'en Biotechnology focuses on antibody-drug conjugates (ADCs) and has developed a pipeline of 13 candidate drugs, with significant partnerships for licensing agreements [15][16] - The company reported a revenue increase of 22.91% year-on-year, reaching 1.227 billion yuan from licensing and collaboration agreements [18] - Despite revenue growth, Ying'en Biotechnology's net loss for the first half of 2025 was 2.074 billion yuan, indicating challenges in profitability [18][19]

Core Insights - The biopharmaceutical industry is characterized by long R&D cycles, high capital investment, and significant risk, making cash flow essential for sustaining operations and innovation [1][2] - The Hong Kong stock market has seen a surge in innovative drug companies going public, with 21 companies listed this year, and notable first-day performances [1] - The STAR Market in China has also opened new financing channels for innovative drug companies, with several firms successfully passing the listing process [2] Group 1: Market Trends - The trend of innovative drug companies going public in Hong Kong is referred to as the "listing wave," with companies like Yinnuo Pharmaceutical seeing first-day gains of up to 206% [1] - The reintroduction of the fifth set of listing standards on the STAR Market has facilitated the listing of companies like Heyuan Biotechnology and Beixin Life [2] Group 2: Company-Specific Insights - Wangshan Wangshui, established in 2013, focuses on small molecule drugs in the fields of neuropsychiatry and reproductive health, but faces challenges in market competition and R&D progress [5] - Financial data indicates significant operational pressure for Wangshan Wangshui, with revenue dropping from 200 million to 11.83 million in 2023-2024, a decline of over 94% [6] - The decline in revenue is primarily attributed to a sharp decrease in licensing income, particularly from the collaboration with Junshi Biosciences on the COVID-19 drug VV116 [7] Group 3: R&D and Product Pipeline - Wangshan Wangshui is attempting to expand the commercial value of VV116 by exploring new indications, such as treatment for respiratory syncytial virus (RSV) [8] - The company has two other core products targeting depression and erectile dysfunction, but both face intense market competition [8] - The company’s financial resources are under pressure due to high R&D expenditures and limited revenue from existing products, necessitating successful fundraising through its IPO [9] Group 4: Competitive Landscape - In contrast to Wangshan Wangshui, Yingen Biotechnology, founded in 2019, specializes in antibody-drug conjugates (ADCs) and has developed a pipeline of 13 candidate drugs [11] - Yingen Biotechnology has accelerated its cash flow through licensing agreements with major companies, resulting in a revenue increase of 22.91% year-on-year [12] - Despite revenue growth, Yingen Biotechnology has experienced a significant increase in net losses, highlighting the challenges of balancing R&D investment with financial performance [12] Group 5: Future Outlook - Analysts emphasize the importance of diversified financing strategies for innovative drug companies to build a "safety net" for R&D [2] - The ability of companies like Yingen Biotechnology to leverage their ADC innovations and partnerships will be crucial for their long-term success and market validation [13]

Company Dynamics - On October 19, the company presented impressive interim analysis data from the HARMONi-6 trial at The Lancet & ESMO [1] - The company revised the HARMONi-3 trial protocol to conduct independent statistical analyses based on histological types [2] Clinical Trial Results - The interim analysis of HARMONi-6 showed a median progression-free survival (mPFS) of 11.1 months compared to 6.9 months, with a hazard ratio (HR) of 0.60 (P<0.0001), indicating a significant improvement [1] - The absolute difference in mPFS between the two groups was 4.24 months, with consistent results across subgroups regardless of PD-L1 expression or liver metastasis [1] - Treatment-related serious adverse events (SAE) were reported at 32.3% for the experimental group versus 30.2% for the control group, with no overall survival (OS) data available yet [1] HARMONi-3 Trial Updates - The HARMONi-3 trial will be divided into two parts: sq-NSCLC (600 patients) and nsq-NSCLC (1000 patients), with separate statistical analyses planned [2] - Enrollment for sq-NSCLC is expected to complete in the first half of 2026, with OS analysis anticipated around the same time [2] - The nsq-NSCLC group aims to complete enrollment in the second half of 2026, with PFS event numbers expected in the first half of 2027 [2] Expansion of Clinical Indications - The company plans to initiate a global multi-regional clinical trial (HARMONi-GI3) for AK112 in colorectal cancer, based on promising II phase data [2] - The trial will compare AK112 combined with chemotherapy against bevacizumab combined with chemotherapy, with an enrollment target of 600 patients [2] Earnings Forecast and Valuation - The company maintains its earnings per share (EPS) forecasts for 2025 and 2026 at 0.09 CNY and 0.59 CNY, respectively [2] - The target price has been adjusted down by 18.2% to 184.00 HKD, reflecting a 50.1% upside potential [3]

Core Viewpoint - Fujian Haixi New Drug Creation Co., Ltd. (referred to as "Haixi New Drug") was listed on the Hong Kong Stock Exchange, with a closing price of 104.20 HKD on the first day, reflecting a 20.60% increase, but it dropped to 101.5 HKD the following day, a decrease of 2.59% [1]. Summary by Sections Share Issuance and Capital Structure - The total number of shares issued under the global offering was 11,500,000 H-shares, with 1,150,000 H-shares available for public offering and 10,350,000 H-shares for international offering [2]. - At the time of listing, the total number of shares issued was 78,707,270 [2]. Pricing and Proceeds - The final offering price was set at 86.40 HKD, resulting in total proceeds of 993.60 million HKD. After deducting estimated listing expenses of 53.47 million HKD, the net proceeds amounted to 940.13 million HKD [4][5]. Use of Proceeds - Approximately 52.0% of the net proceeds is expected to be used for ongoing investment in research and development to advance the drug pipeline and enrich the product portfolio. About 23.0% is anticipated for enhancing R&D capabilities and seeking collaboration opportunities. Additionally, 8.0% is planned for strengthening commercialization capabilities and expanding market influence, while 7.0% is allocated for improving and optimizing R&D and production systems, and 10.0% for working capital and other general corporate purposes [6]. Company Overview - Haixi New Drug is a commercial-stage pharmaceutical company that integrates R&D, production, and sales capabilities, with a pipeline of innovative drugs under development [6]. Financial Performance - The company's revenues for the years 2022, 2023, 2024, and the first five months of 2025 were 212.5 million, 316.6 million, 466.7 million, and 249.2 million RMB, respectively. The net profits for the same periods were 69.0 million, 117.5 million, 136.1 million, and 90.2 million RMB [7][8]. - The net cash flow from operating activities for the same periods was 85.3 million, 147.1 million, 163.9 million, and 80.1 million RMB [9]. Research and Development Pipeline - As of July 2025, Haixi New Drug has only four innovative drugs in the pipeline, all in early clinical stages. These include a multi-mechanism immune modulator C019199 for treating osteosarcoma and other malignancies, an oral small molecule drug HXP056 recently approved for clinical trials targeting wet age-related macular degeneration, and two other drugs for tumors and respiratory diseases still in preclinical research [10].

Market Performance - The Hang Seng Index rose by 2.4% to 25,859 points, while the Hang Seng China Enterprises Index increased by 2.5% to 9,233 points[1] - Total turnover in Hong Kong stocks was HKD 239.2 billion, lower than HKD 314.6 billion on the previous Friday, indicating market caution despite the rise[1] - Key sectors such as Energy, Consumer Discretionary, Information Technology, and Conglomerates saw increases of 2.8%, 3.3%, 3.2%, and 2.0% respectively, while Materials fell by 0.7%[1] Economic Indicators - China's Q3 GDP grew by 4.8%, surpassing the market expectation of 4.7%[3] - Industrial output in September rose by 6.5%, exceeding the forecast of 5.0%[3] - Retail sales increased by 3.0% year-on-year, aligning with expectations[3] Real Estate Trends - New home sales in 30 major cities reached 1.98 million square meters, down 25.4% year-on-year but improved from a previous decline of 41.4%[3] - New housing starts fell by 15.0% to 55.98 million square meters, a smaller decline compared to 19.8% in August[3] - The price index for new residential properties in 70 major cities dropped by 2.7% year-on-year, with first, second, and third-tier cities experiencing declines of 0.7%, 2.1%, and 3.4% respectively[3] Sector Highlights - Li Auto (9863 HK) saw a 6.2% increase in stock price after its founder and shareholders increased their holdings[4] - UBTECH (9880 HK) surged by 9.8% following a procurement order worth HKD 126 million for its latest humanoid robot[4] - The Hang Seng Healthcare Index rose by 1.3%, with major pharmaceutical companies showing stable performance despite market concerns[4]

Group 1 - The company, 旺山旺水, has passed the main board listing hearing of the Hong Kong Stock Exchange, with 中信证券 as its sole sponsor [1] - The company possesses nine innovative asset pipelines focusing on three therapeutic areas: neuropsychiatry, reproductive health, and viral infections [1] - Core products include LV232 for the treatment of major depressive disorder and TPN171 for erectile dysfunction [1] Group 2 - The company has achieved commercialization through the sales of dapoxetine, rebapentine, and products like TPN171 and VV116 in Uzbekistan [1] - According to Zhi Shi Consulting, the Chinese antiviral drug market, neuropsychiatric drug market, reproductive health drug market, and antiviral drug market are projected to grow from RMB 103.9 billion, RMB 36.2 billion, and RMB 20.3 billion in 2024 to RMB 123.5 billion, RMB 42.2 billion, and RMB 40.3 billion by 2035, respectively [1]

Core Viewpoint - Anke Biopharma announced the presentation of clinical research data for its innovative drug HuA21 at the ESMO annual meeting, highlighting its efficacy and safety in treating HER2-positive advanced gastric/gastroesophageal junction adenocarcinoma [1] Group 1: Company Developments - Anke Biopharma will present the latest research findings on HuA21, a recombinant anti-HER2 humanized monoclonal antibody injection, at the ESMO annual meeting in Berlin from October 17 to 21, 2025 [1] - The clinical study data for HuA21 in combination with trastuzumab and chemotherapy further confirms its good anti-tumor activity and tolerable safety profile [1] Group 2: Industry Implications - The results from the clinical research provide support for the Phase III clinical trial, potentially accelerating the drug development process [1]

Core Insights - The National Medical Products Administration has approved the launch of the innovative drug Remabizine Injection by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, which is used in conjunction with MediBeacon Inc's TGFR device to assess patients' glomerular filtration rate (GFR) [1][2] - This approval reflects Hangzhou's commitment to high-quality development in the biopharmaceutical industry, translating policy into practice through regulatory support and service empowerment [1][2] Group 1 - The Hangzhou Market Supervision Administration has implemented a "one-stop" service system to address the challenges of long, complex, and difficult drug development cycles, enhancing communication and support for key enterprises [1][2] - The city has established a collaborative "Hangzhou service model" that includes a three-level coordination mechanism to ensure timely communication of policies and responses to issues [1][2] Group 2 - The administration has adopted a full lifecycle service approach for the innovative drug project, optimizing drug registration and inspection processes to expedite approvals [2] - By coordinating with higher-level agencies and providing tailored support, the administration has significantly shortened the approval timeline for the drug, showcasing the acceleration of innovative services in Hangzhou [2] - The successful approval of Remabizine Injection exemplifies the synergy between market regulation and corporate innovation, with plans for continued reforms to further enhance the biopharmaceutical industry's development [2]

香港聯合交易所有限公司與證券及期貨事務監察委員會對本聆訊後資料集的內容概不負責，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聆訊後資料集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。 四川百利天恒藥業股份有限公司 （「本公司」） （於中華人民共和國註冊成立的股份有限公司） 的聆訊後資料集 警告 本聆訊後資料集乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證 監會」）的要求而刊發，僅用作提供資訊予香港公眾人士。 本聆訊後資料集為草擬本，其內所載資料並不完整，亦可能會作出重大變動。您閱覽本文件， 即代表您知悉、接納並向本公司、其聯席保薦人、整體協調人、顧問或包銷團成員表示同意： 本公司招股章程根據香港法例第32章《公司（清盤及雜項條文）條例》呈交香港公司註冊處處長 註冊前，本公司不會向香港公眾人士提出要約或邀請。倘於適當時候向香港公眾人士提出要約 或邀請，準投資者務請僅依據呈交香港公司註冊處處長註冊的本公司招股章程作出投資決定； 有關文本將於發售期內向公眾刊發。 (a) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的；投資者不應根 ...