来源：医线Insight 春节刚过，又一家创新药企决定冲刺港交所。 2月25日，天辰生物医药（苏州）股份有限公司（简称"天辰生物"）递交招股书。 这家成立于2020年10月的创新药企，在短短5年时间里，不仅将核心管线一路推至临床III期，更在行业 公认的"资本寒冬"中逆势完成了7轮、累计5.215亿元的融资。 其中，在2025年5月完成的C轮融资中，天辰生物投后估值一举突破20亿元大关。 | 融资 | | | 融资金额 | 投资后估值 | | | --- | --- | --- | --- | --- | --- | | 轮次 | 协议签署日期 | 资金恐救结清日期 | (人民币) | (人民币) | 参与的投资方 | | A$8 | 2020年12月30日及 | | 9850 | | 上海安壮、OFC博晖基金、上海友宣 | | | 2021年6月20日 | 2021年7月29日 | 万元 | 3.985亿元 | 、石药仙瞳、永石汇金、东南投资、 | | | | | | | 安徽安元、仙疆顺创、新生华创 | | | 2022年5月23日 | 2025年4月1日 | 4000 | | 刘博士、湖州友宣(出资责任 ...

来源：企业上市 港交所官网2月25日晚间披露，天辰生物医药（苏州）股份有限公司（以下简称"天辰生物"）已重新提 交上市申请，国金证券（香港）继续担任独家保荐人。这是该公司继2025年8月首次递表失效后的再次 冲刺。 | [編纂]項下的[編纂]數目 : [編纂]股H股(視乎[編纂]行使 | | --- | | 與否而定) | | [编纂]數目 .. [编纂]股H股(可予[编纂]) | | [編纂]數目 .. [编纂]股H股(可予重新分配及视乎 | | [编纂]行使與否而定) | | 最高[編纂] : 每股H股[編纂],另加1.0％經紀佣金 | | 0.0027%證監會交易徵費、0.00015 | | 曾財局交易徵費及0.00565% 香港聯 | | 所交易費(須於[編纂]時以港元繳足 | | 多繳款項可予退還) | | 面值 每股H股人民幣1.00元 | | 【漫畫】：【遍靈】 | | 墙安促施 · [ · [ · [ · [ · [ · [ · [ | 这家成立于2020年的生物制药公司，专注于过敏及自身免疫性疾病的新药研发。其最引人注目的标签， 是89岁的联合创始人孙乃超博士——他正是全球第一款抗过敏抗体药 ...

智通财经APP获悉，据港交所2月25日披露，天辰生物医药(苏州)股份有限公司(简称：天辰生物医药)向港交所主板递交上市申请，国金证券(香港)为独家保 荐人。该公司曾于2025年8月21日递表港交所。 公司简介 招股书显示，天辰生物医药是一家临床阶段生物制药公司，主要专注于针对过敏性及自身免疫性疾病的生物药物的自主发现与开发。公司拥有(i)一款核心产 品LP-003，一种抗IgE抗体，主要作用是阻断血液及组织中的游离IgE，从而抑制发生IgE介导的过敏反应，旨在用于治疗过敏性疾病，包括季节性过敏性鼻 炎(AR)、慢性自发性荨麻疹(CSU)、过敏性哮喘及其他过敏性疾病；及(ii)一款主要产品。 于最后实际可行日期，公司已在中国启动八项关于LP-003的临床试验，其中两项已完成，其馀六项仍在进行中。在CSUII期临床试验的中期分析结果中， LP-003在治疗CSU方面展现出优于奥马珠单抗的显著疗效(起效迅速、疗效良好且作用持久)。此外，LP-003在针对经标准治疗后病情控制不佳的中重度季节 性AR的中国II期临床试验中显示出良好的疗效和安全性。目前，一项用于治疗季节性AR的III期临床试验正在中国开展。 作为双功能 ...

Core Viewpoint - The recent leadership change at Newnoway, with a young manager taking over amidst significant financial losses, highlights the challenges faced by Chinese pharmaceutical companies in their transformation efforts [1][15]. Management Changes - Newnoway appointed Dai Long, a 1992-born executive, as the new general manager, who previously served as the board secretary and will also continue as the financial director [1][17]. - The former general manager, Yao Bing, will remain as the chairman [17]. - Dai Long's annual salary is only 223,200 yuan despite holding multiple positions, reflecting the company's current financial constraints [5][19]. Financial Performance - Newnoway expects a net loss of 170 million to 255 million yuan for 2025, marking a decline of 416% to 575% compared to the previous year, which will be the company's first annual loss since its listing in 2019 [15][20]. - The company's net profit dropped from 726 million yuan in 2022 to 43.4 million yuan in 2023, a decrease of 40.18%, and further to 5.37 million yuan in 2024, a decline of 87.63% [6][20]. - The decline in performance is attributed to increased R&D expenses, expanded losses from acquired subsidiaries, and decreased gross margins in traditional business lines [20][21]. Business Transformation - Newnoway is transitioning from traditional functional raw materials, primarily caffeine, to innovative pharmaceuticals, including antibody-drug conjugates and mRNA vaccines [10][24]. - The company acquired a 51% stake in Giant Stone Biotech in 2023 and increased its stake to 80% in 2025, but the subsidiary has not yet contributed positively to overall performance [10][24]. - The strategic partnership with AstraZeneca, potentially worth over $17 billion, offers a glimmer of hope for the company's innovative drug pipeline [12][25]. Challenges and Outlook - Newnoway faces the challenge of balancing its declining traditional business with the need for substantial investment in innovative drug development [13][25]. - As of the third quarter of 2025, the company's debt ratio rose to 32.94%, indicating increased financial pressure [13][25]. - The success of Dai Long's leadership will be critical in navigating these challenges and achieving a successful transition from a traditional raw material supplier to an innovative pharmaceutical company [26][27].

Core Viewpoint - The National Medical Products Administration (NMPA) of China has mandated the addition of warnings regarding neuropsychiatric adverse reactions in the instructions for Montelukast formulations, including serious reactions such as depression and suicidal tendencies, with a deadline for compliance set for March 12, 2026 [1][4]. Group 1: Regulatory Changes - The NMPA requires all Montelukast product license holders in China to revise their product instructions to include warnings about neuropsychiatric adverse reactions [1]. - The revisions must be submitted to the NMPA or provincial drug regulatory departments by March 12, 2026, and all existing product labels must be updated within nine months after the submission [1]. Group 2: Market Context - Montelukast sodium, originally developed by Merck (brand name: Singulair), is a potent selective leukotriene receptor antagonist used for asthma prevention and treatment in children aged 2 to 14 [3]. - Following the expiration of Merck's patent, domestic companies have begun to produce generic versions, with 62 approvals found on the NMPA website from various manufacturers [3]. Group 3: Adverse Reactions and Clinical Implications - The revision of Montelukast's instructions is based on adverse reaction assessments, with the FDA in the U.S. having previously issued a black box warning for similar neuropsychiatric adverse reactions [4][5]. - Reports of adverse reactions, including depression and suicidal behavior, have been documented, with a study indicating that 86.12% of Montelukast prescriptions in a certain hospital were for off-label uses [5][8]. Group 4: Sales and Competitive Landscape - Montelukast ranked third in sales among asthma medications in China for the first three quarters of 2024, with total sales reaching 1.33 billion yuan [9]. - The competitive landscape includes 24 companies with 42 formulations of Montelukast available, with significant market shares held by companies like Eurofarma and Shanghai Anbisen [9]. Group 5: Emerging Treatments - The emergence of biologic therapies is changing the treatment landscape for pediatric asthma, with several new biologics approved for use in children [10]. - The NMPA's revisions to Montelukast's labeling serve as a reminder for the need for safe and effective prescribing practices as new treatment options become available [10].

Core Insights - A new experimental vaccine named "IgE-K" has been developed by scientists at the Toulouse Institute of Infection and Inflammation, showing promise in preventing severe allergic reactions in mice for up to one year [1][2] - The vaccine targets Immunoglobulin E (IgE), which is responsible for triggering allergic responses, and aims to reduce free IgE levels that can initiate these reactions [1] Group 1: Vaccine Mechanism and Efficacy - The vaccine induces the production of antibodies that bind to IgE, preventing it from interacting with immune cell receptors, thereby significantly lowering the likelihood of allergic reactions upon exposure to allergens [1] - In animal trials, 8 out of 9 control mice without the vaccine died within 30 minutes of allergen exposure, while all vaccinated mice exhibited only mild allergic symptoms and no fatalities [1] Group 2: Comparison with Existing Treatments - The mechanism of the new vaccine is similar to that of the approved monoclonal antibody drug, Omalizumab, which requires bi-weekly injections to maintain its effects, whereas the new vaccine is expected to offer longer-lasting protection [2] Group 3: Future Considerations - Further validation is needed to determine if the vaccine could cause unexpected allergic reactions in humans and whether the long-term reduction of IgE might impair the body's ability to combat parasitic infections [2]

Group 1: Company Research - The company, CSPC Pharmaceutical Group (01093), is rated as "Buy" with a target price of HKD 10.03, representing a potential upside of 31.3% from the current price of HKD 7.64[5][6]. - The market capitalization of CSPC Pharmaceutical Group is HKD 880.32 billion, with 11.522 billion shares issued[5]. - The adjusted net profit for the first three quarters of 2025 decreased by 15.2%, with revenue at HKD 19.89 billion, down 12.3% year-on-year[6]. Group 2: Financial Performance - The gross profit margin for the company is 65.6%, with a decrease in sales and administrative expense ratios by 4.4 and 0.8 percentage points to 31.1% and 3.1%, respectively[6]. - R&D expenses as a percentage of revenue increased by 6.3 percentage points to 27.1%[6]. - The net profit attributable to shareholders was HKD 3.51 billion, down 7.1%, with a net profit margin of 15.5%, a decrease of 2.1 percentage points[6]. Group 3: Segment Performance - The revenue from the finished drug segment was HKD 15.45 billion, down 17.2%, with a 25.5% decline in drug revenue to HKD 13.91 billion[6][7]. - The raw material drug segment saw revenue of HKD 1.79 billion, up 22.3%, while the functional food segment reported revenue of HKD 1.43 billion, up 11.2%[6][7]. - The profit margin for the finished drug segment was 20.9%, down 1.8 percentage points, while the vitamin C segment's profit margin increased by 3.6 percentage points to 11.0%[6][7]. Group 4: Future Outlook - The company plans to maintain dividends in the second half of the year at least at the same level as the first half, which was HKD 0.14 per share[6]. - The target market value for CSPC Pharmaceutical Group is estimated at HKD 116.5 billion, with a corresponding price-to-earnings ratio of 25.2 times for 2025 and 29.4 times for 2026[9].

Core Viewpoint - Haitong International maintains an "outperform" rating for CSPC Pharmaceutical Group (01093) with a target price of HKD 11.34, noting a revenue decline in the first three quarters but signs of recovery in Q3, with a 10% quarter-on-quarter growth in prescription drug revenue and a 27% year-on-year increase in net profit attributable to shareholders [1][2]. Financial Performance - For the first nine months of 2025, CSPC achieved revenue of CNY 19.9 billion, a 12% year-on-year decline, with prescription drug revenue at CNY 15.5 billion (down 17%), API revenue at CNY 3 billion (up 10%), and functional foods and other businesses at CNY 1.4 billion (up 11%) [2]. - The gross margin was 65.6%, down 4.9 percentage points year-on-year; R&D expenses were CNY 4.2 billion (up 8%), with an R&D expense ratio of 21.0% (up 3.9 percentage points); the sales expense ratio was 24.1% (down 5.1 percentage points) [2]. - In Q3 2025, CSPC reported revenue of CNY 6.6 billion, a 3% year-on-year increase and a 6% quarter-on-quarter increase, with prescription drug revenue at CNY 5.2 billion (up 2% year-on-year, up 10% quarter-on-quarter) [2]. Prescription Drug Business - In Q3 2025, all segments of the prescription drug business showed improvement, confirming the bottom of the fundamentals, with total prescription drug revenue of CNY 4.7 billion and drug revenue of CNY 4.7 billion (up 8% quarter-on-quarter) [3]. - Specific revenue breakdown includes: - Neurological system: CNY 1.91 billion (down 4% year-on-year, up 4% quarter-on-quarter) - Oncology: CNY 590 million (down 47% year-on-year, up 19% quarter-on-quarter) - Anti-infection: CNY 830 million (down 9% year-on-year, up 12% quarter-on-quarter) - Cardiovascular: CNY 470 million (up 18% year-on-year, up 4% quarter-on-quarter) - Respiratory: CNY 320 million (up 73% year-on-year, up 28% quarter-on-quarter) - Metabolism: CNY 250 million (up 14% year-on-year, up 8% quarter-on-quarter) - Other therapeutic areas: CNY 360 million (up 26% year-on-year, down 4% quarter-on-quarter) [3]. - The company expects a 5% revenue growth in the second half of the year for the prescription drug segment (excluding authorized revenue) [3]. Asset Expansion and R&D Progress - The SYS6010 (EGFRADC) clinical trial is progressing well, with significant potential for external licensing; multiple technology platforms and products are also expected to expand internationally [4]. - Management plans to present clinical data for SYS6010 at major conferences next year and publish data in top academic journals [5]. - The small RNA platform has five assets entering clinical stages, focusing on liver-targeted and multi-target products, with plans for new products in weight loss and muscle gain to enter clinical trials next year [6]. - The PD-1/IL15 pipeline is a key focus, with over 90 patients enrolled in dose-exploration trials, showing promising safety and efficacy results [6].

Core Viewpoint - Haitong International maintains an "outperform" rating for CSPC Pharmaceutical Group (01093) with a target price of HKD 11.34, noting a revenue decline in the first three quarters but signs of recovery in Q3, with a 10% quarter-on-quarter growth in traditional medicine revenue and a 27% year-on-year increase in net profit attributable to shareholders [1]. Financial Performance - For the first nine months of 2025, CSPC achieved revenue of CNY 19.9 billion, a 12% year-on-year decline, with traditional medicine revenue at CNY 15.5 billion (down 17%), API revenue at CNY 3 billion (up 10%), and functional foods and other businesses at CNY 1.4 billion (up 11%) [1]. - The gross margin was 65.6%, down 4.9 percentage points year-on-year; R&D expenses were CNY 4.2 billion (up 8%), with an R&D expense ratio of 21.0% (up 3.9 percentage points); the sales expense ratio was 24.1% (down 5.1 percentage points) [1]. - The net profit attributable to shareholders for the first three quarters was CNY 3.5 billion, a 7% year-on-year decline [1]. Q3 Performance - In Q3 2025, CSPC reported revenue of CNY 6.6 billion, a 3% year-on-year increase and a 6% quarter-on-quarter increase, with traditional medicine revenue at CNY 5.2 billion (up 2% year-on-year, up 10% quarter-on-quarter) [2]. - The gross margin was 65.6%, down 2.1 percentage points year-on-year; R&D expenses were CNY 1.5 billion (up 12.3%), with an R&D expense ratio of 22.7% (up 1.8 percentage points); the sales expense ratio was 26.4% (down 2.4 percentage points) [2]. - The net profit attributable to shareholders for Q3 was CNY 960 million, a 27% year-on-year increase but a 10% quarter-on-quarter decline [2]. Traditional Medicine Business - In Q3, all segments of the traditional medicine business showed improvement, indicating a bottoming out of fundamentals, with traditional medicine revenue of CNY 4.7 billion and drug revenue of CNY 4.7 billion (up 8% quarter-on-quarter) [3]. - Specific revenue breakdown includes: - Neurological system: CNY 1.91 billion (down 4% year-on-year, up 4% quarter-on-quarter) - Oncology: CNY 590 million (down 47% year-on-year, up 19% quarter-on-quarter) - Anti-infection: CNY 830 million (down 9% year-on-year, up 12% quarter-on-quarter) - Cardiovascular: CNY 470 million (up 18% year-on-year, up 4% quarter-on-quarter) - Respiratory: CNY 320 million (up 73% year-on-year, up 28% quarter-on-quarter) - Metabolism: CNY 250 million (up 14% year-on-year, up 8% quarter-on-quarter) - Other therapeutic areas: CNY 360 million (up 26% year-on-year, down 4% quarter-on-quarter) [3]. - The company expects a 5% revenue growth in the traditional medicine segment (excluding authorized revenue) in the second half of the year compared to the first half [3]. Asset Expansion and R&D Progress - The SYS6010 (EGFRADC) clinical trial is progressing well, with significant potential for external licensing; multiple technology platforms and products are expected to expand internationally [4]. - Management plans to present clinical data for SYS6010 at major academic conferences next year and publish lung cancer clinical data in top journals [5]. - The small RNA platform has five assets entering clinical stages, focusing on liver-targeted and multi-target products, with plans for new products in weight loss and muscle gain to enter clinical trials next year [6]. - The PD-1/IL15 pipeline is a key focus, with over 90 patients enrolled in dose-exploration trials, showing promising safety and efficacy results [6].

Investment Rating - The report maintains an "Outperform" rating for CSPC Pharmaceutical Group [2][12][23] Core Insights - In 9M25, CSPC achieved revenue of CNY 19.9 billion, a year-on-year decrease of 12%, with finished drug revenue at CNY 15.5 billion, down 17% year-on-year [3][16] - The gross profit margin (GPM) was reported at 65.6%, a decline of 4.9 percentage points year-on-year [3][16] - Management anticipates a return to positive growth in finished drug sales by 2026, despite uncertainties surrounding the renewal rules for generic drug procurement [3][16] Financial Performance Summary - Revenue projections for FY25 and FY26 have been adjusted to CNY 27.3 billion and CNY 30.1 billion, respectively, reflecting slower-than-expected out-licensing income recognition [9][23] - Net profit attributable to shareholders is forecasted at CNY 5.0 billion for FY25 and CNY 5.1 billion for FY26, down from previous estimates [9][23] - The company reported a net profit of CNY 3.5 billion in 9M25, a decrease of 7% year-on-year [3][16] Segment Performance - In 3Q25, all segments of finished drugs showed quarter-on-quarter improvement, with total finished drug revenue reaching CNY 4.7 billion, an increase of 8% quarter-on-quarter [5][18] - Notable revenue contributions in 3Q25 included CNY 1.91 billion from the nervous system segment and CNY 0.32 billion from the respiratory system, which saw a 73% year-on-year increase [21][18] Research and Development - R&D expenses for 9M25 were CNY 4.2 billion, an increase of 8% year-on-year, with an R&D expense ratio of 21.0% [3][16] - The company is advancing multiple clinical pipelines, including SYS6010, with clinical data expected to be released in 2026 [20][22] Out-Licensing Opportunities - The report highlights significant potential for out-licensing multiple assets, including SYS6010, which is progressing well in clinical trials [6][19] - The company's business development strategy is entering a phase of tangible results, with expectations for continuous deals that will enhance net profit [6][19]