格隆汇5月20日丨三生制药(01530.HK)发布公告，2025年5月19日，公司、沈阳三生制药有限责任公司 ("沈阳三生"，公司的全资附属公司)及辉瑞公司("辉瑞")已订立独家许可协议。三生国健药业(上海)股份 有限公司("三生国健"，公司附属公司)亦将透过加入协议作为签署方加入。 该许可产品为集团基于其专有CLF2平台自主研发的靶向PD-1/VEGF的双特异性抗体。其目前正在中国 进行多项临床研究，包括计划启动获国家药品监督管理局("国家药监局")药品审评中心("CDE")批准的 用于一线治疗PD-L1阳性局部晚期或转移性非小细胞肺癌("NSCLC")的III期临床研究，并已获得中国突 破性疗法认定资格。此外，SSGJ-707注射液正在中国进行多项II期研究，包括联合化疗一线治疗晚期 NSCLC、转移性结直肠癌及晚期妇科肿瘤。其亦获得了美国食品药品监督管理局关于其新药临床试验 申请的批准。 根据许可协议，集团将收到12.50亿美元的首付款，并可获得总额最多为48亿美元的潜在付款，包括开 发、监管批准及销售里程碑付款。上述所有款项均不可退还且不可抵扣。集团亦将就许可地区的产品净 销售额收取双位数百分比的梯度 ...

5月19日上榜港股通成交活跃榜个股中，三生制药为近一个月首次上榜。 证券时报·数据宝统计显示，5月19日港股通（包括沪市港股通及深市港股通）成交活跃股合计成交 378.81亿港元，占当日港股通成交金额的44.83%，净买入金额38.58亿港元。 上榜的成交活跃股中，阿里巴巴-W成交额为98.74亿港元，成交金额居首；其次是小米集团-W、腾讯控 股，成交金额分别为88.56亿港元、51.58亿港元。 以上榜次数统计，5月19日上榜个股中，近一个月上榜次数最多的是阿里巴巴-W、美团-W等，近一个 月均上榜17次，最受港股通资金关注。 三生制药为近一个月首次上榜，当日港股通成交额为18.13亿港元，成交净买入4.01亿港元，该股当日收 盘上涨13.81%。（数据宝） 5月19日港股通成交活跃股榜单 | 证券 | 证券简称 | 成交金额（亿 | 净买入金额（亿 | 近一个月上榜 | 最新收盘价 | 日涨跌幅 | | --- | --- | --- | --- | --- | --- | --- | | 代码 | | 港元） | 港元） | 次数 | （港元） | （%） | | 00700 | 腾讯控股 | 51.5 ...

相关ETF方面，截至发稿，港股创新药ETF（159567）高开高走，现涨1.41%。成分股中，三生制药涨 超5%，再鼎医药、远大医药、君实生物、信达生物等股涨幅居前。 （1）当前政策对于创新药行业的扶持较为清晰和明确，商保目录有望进一步推动创新药在患者当中的 可及性。 （2）从创新药企业自身来看，临床数据读出持续表现优异，头部创新药企业有望实现盈利提升创新药 产业信心，License-out项目数量有望持续提升，创新药出海有望持续得到市场认可。 5月9日，恒生指数高开0.35%，创新药板块持续活跃。 港股创新药ETF（159567）紧密跟踪港股通创新药指数（987018），该指数反映港股通生物科技产业上 市公司的运行特征。 消息面上，据中证报，近期，中国创新药行业利好消息不断，行业景气度提升。日前备受瞩目的美国癌 症研究协会（AACR）年会在芝加哥召开，多家中国创新药企受邀参会。与此同时，信达生物、康方生 物等企业相关产品取得阶段性突破；部分创新药企业一季报和年报数据亮眼，实现显著同比增长。业内 人士认为，随着政策支持、市场认可提升、投融资环境改善以及研发成果逐步显现，创新药板块发展前 景广阔。受益于多个积极 ...

Financial Performance - For the fiscal year ending December 31, 2024, the company's revenue reached RMB 9,107,978,000, representing a 16.5% increase from RMB 7,815,938,000 in 2023[9] - The gross profit for 2024 was RMB 7,828,376,000, up from RMB 6,641,640,000 in 2023, indicating a gross margin improvement[9] - The adjusted operating EBITDA for 2024 was RMB 3,402,296,000, a 23.0% increase from RMB 2,768,353,000 in 2023[9] - The company maintained a leverage ratio of 19.7% in 2024, down from 29.3% in 2023, indicating improved financial stability[9] - The total assets of the company reached RMB 24,212,740,000 in 2024, an increase from RMB 23,625,028,000 in 2023[9] - The company's revenue for the reporting period was approximately RMB 9,108.0 million, an increase of about RMB 1,292.1 million or approximately 16.5% compared to RMB 7,815.9 million for the year ended December 31, 2023[66] - Sales of the core product, Teibiao, increased to approximately RMB 5,062.0 million, up by about RMB 857.4 million or approximately 20.4%, accounting for about 55.6% of total revenue[66] - The total sales of Yibiao and Saibol reached approximately RMB 1,018.5 million, an increase of about RMB 78.2 million or approximately 8.3% compared to RMB 940.3 million for the year ended December 31, 2023[67] - The sales in the hair loss sector amounted to approximately RMB 1,351.8 million, an increase of about RMB 209.5 million or approximately 18.3% compared to RMB 1,142.3 million for the year ended December 31, 2023[68] - Net profit attributable to equity holders of the parent company was approximately RMB 2,090.3 million, an increase of RMB 541.1 million or 34.9% from RMB 1,549.2 million[83] - Basic earnings per share for the reporting period were approximately RMB 0.86, an increase of 34.4% from RMB 0.64 for the year ended December 31, 2023[84] Research and Development - Research and development costs increased significantly to RMB 1,326,530,000 in 2024, compared to RMB 794,794,000 in 2023, reflecting a focus on innovation[9] - The group is focusing on innovative drug development, particularly in oncology, nephrology, and autoimmune diseases, with significant clinical advancements expected in 2025[12] - The company has 30 key products in active development, with 29 of them being innovative drugs in mainland China[3] - The group has 30 products in its research pipeline, with key clinical advancements in blood and tumor fields, including multiple Phase II and III trials[11] - The company has a research team of nearly 700 scientists focused on developing innovative biopharmaceuticals and small molecules for unmet medical needs[45] - The company is actively preparing for the market launch of several innovative drugs, including Baerisu (Paclitaxel Oral Solution) and Teisen, with expectations of annual new drug commercialization starting in 2025[62] - The company has received approval for multiple new drugs, including 5% minoxidil foam for male pattern baldness and rhTPO for treating chronic ITP in children[42] - The company has completed the Phase III clinical trial for SSS06, a long-acting erythropoietin, for the treatment of anemia in chronic kidney disease, achieving the primary endpoint[50] - The Phase III clinical trial for the anti-IL-17A monoclonal antibody (608) has successfully met all efficacy endpoints, with an NDA submitted in November 2024 and accepted[50] Market Presence and Distribution - The company’s market share for its flagship product, Teplizumab, is projected to be 66.6% in the Chinese market for thrombocytopenia treatment in 2024[2] - The company’s distribution network reached over 11,000 hospitals and medical institutions across mainland China during the reporting period[4] - The group has established strategic partnerships for the commercialization of several products, including semaglutide injection and paclitaxel oral solution, enhancing its market presence[14] - The company has established a large sales and distribution network in mainland China, comprising 2,653 sales and marketing personnel, 1,248 distributors, and 1,811 third-party promoters[60] - The company’s products are sold in over 3,000 tertiary hospitals and nearly 9,000 secondary or lower-level hospitals and medical institutions across all provinces, autonomous regions, and municipalities in mainland China[60] Strategic Partnerships and Collaborations - The company has signed a cooperation agreement with Hanyu Pharmaceutical for the development and exclusive supply of Semaglutide injection for weight management, with a milestone payment of up to RMB 270 million, including RMB 45 million for preclinical technology achievements[21] - The company has obtained exclusive commercialization rights for Paclitaxel oral solution in mainland China and Hong Kong through a collaboration with Haihe Pharmaceutical, with milestone payments tied to R&D and sales[23] - The company has secured exclusive commercialization rights for Crizotinib in specific indications in mainland China through a partnership with Guangdong Dongyangguang Pharmaceutical, with initial and milestone payments involved[24] - The company has reached an agreement with InnoCare Pharma for the commercialization of HER2 ADC drug DB-1303 in mainland China, Hong Kong, and Macau, with upfront and milestone payments based on development progress[25] - The company is actively seeking global partnerships to expand its product pipeline internationally, preparing for competitive global market entry[16] Regulatory and Compliance - The drug development process is time-consuming and costly, with no guarantee of success, and may face delays due to regulatory requirements from the National Medical Products Administration[107] - The company emphasizes compliance with significant laws and regulations that impact its operations and stakeholder relationships[141] - The company may lose market share and face adverse impacts on revenue and profitability if it fails to win bids in provincial tendering processes for selling products to Chinese hospitals[105] - Under the current government centralized procurement framework, the company anticipates significant price reductions for its products, which could lead to decreased revenue and profit levels[106] Management and Governance - The management team includes experienced professionals with extensive backgrounds in pharmaceuticals and biotechnology, contributing to the company's strategic initiatives[120] - The board of directors includes independent non-executive members with rich experience in finance and pharmaceuticals, ensuring robust governance[125][126] - The remuneration committee has been established to review the group's remuneration policies and the compensation structure for all directors and senior management, considering the group's operational performance and individual contributions[167] Shareholder Information - The board proposed a final dividend of HKD 0.25 per share for the year ending December 31, 2024, consistent with the previous year's dividend[140] - As of December 31, 2024, the company's distributable reserves were approximately RMB 2,652.7 million, a decrease from RMB 3,382.4 million as of December 31, 2023[151] - The total number of issued shares is 2,395,573,912[171] - Major shareholder Decade Sunshine Limited holds 476,774,553 shares, representing 19.90% of the issued shares[177] - The company repurchased a total of 43,346,500 shares during the reporting period, with a total cash consideration of HKD 266,284,340[180] Risks and Challenges - There is a risk that partners or collaborators may not fulfill their obligations, which could lead to conflicts or inefficiencies in cooperation[113] - The company may struggle to maintain existing partnerships or establish new ones, which could negatively impact its ability to develop new products[108] - The company faces potential reputational damage and regulatory scrutiny if employees or third-party agents engage in corrupt practices[111] - The company’s ability to manufacture and launch sufficient quantities of products economically may be limited, affecting its market presence[109]

Group 1 - The core point of the article is that Sangfor Pharmaceutical's dual-specific antibody (code: 707) has been included in the list of breakthrough therapies by the National Medical Products Administration, targeting first-line treatment for PD-L1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC) [1][2] - Lung cancer has the highest incidence and mortality rates among all cancers, with non-small cell lung cancer accounting for approximately 80%-85% of all lung cancer cases [1] - Current treatments for NSCLC, including anti-PD-1/L1 monotherapy and combination chemotherapy, show limited effectiveness, with a 5-year survival rate of only 17%-30% [1] Group 2 - The dual-specific antibody 707 is developed based on the CLF2 patent platform and can simultaneously inhibit VEGF and PD-1, showing significant anti-tumor activity and good safety profile in clinical trials [1] - Sangfor Pharmaceutical is also advancing clinical research for 707 in other cancers such as colorectal cancer, endometrial cancer, and ovarian cancer, and has received FDA IND approval for 707 [2] - The company has partnered with BaiLi Tianheng to explore the potential of 707 in combination with BL-B01D1 for solid tumors in China, enhancing the application prospects of 707 [2]

Summary of the Conference Call for Sanofi Pharmaceutical Company Overview - Sanofi Pharmaceutical was founded in 1993 by General Lou Dan, with a military background contributing positively to its long-term development [3] - The company has evolved into a comprehensive pharmaceutical enterprise focusing on oncology, hematology, and consumer healthcare, achieving over 50% market share in key products [3][4] Core Business Insights - **Product Focus**: Sanofi's key products include Teibiao, Yipiao, and Yisai Pu, with a strong emphasis on innovation through self-research and business development (BD) [3][5] - **Clinical Trials**: The company is nearing completion of Phase II clinical trials for its PD-L1/VEGF dual antibody, which could significantly impact non-small cell lung cancer treatment [3][8] - **Sales Projections**: Teibiao is expected to exceed 5 billion yuan in sales for 2024, with further growth anticipated from new indications and lifted insurance restrictions [3][10] Innovation and R&D - **Strategic Investments**: Sanofi has made strategic investments in cutting-edge technologies such as IDFC, cell therapy, and CAR-T dual antibodies [3][5] - **Autoimmune Disease Focus**: The company is targeting well-validated overseas markers in autoimmune diseases, maintaining a competitive position in the market [6] Collaborations - Sanofi has partnered with BeiGene to co-develop PD-L1/VEGF dual antibodies and ADC combinations, aiming to replace existing first-line treatments [7] Consumer Healthcare - **Market Leadership**: The product Mandu has become the market leader in both hospital and retail settings, with projected sales of over 1.3 billion yuan in 2025 [11] - **New Product Launches**: Bever, for moderate acne, is expected to reach 500,000 prescriptions in North America in 2024, translating to approximately $300 million in sales [11] Financial Performance - **EPO Segment**: The EPO segment is projected to achieve an 8%-9% growth rate in the first half of 2024, with a long-acting second-generation product expected to be approved in late 2025 [10] - **Overall Growth Strategy**: Sanofi's strategy of focusing on major products ensures stable growth over the next 2-3 years, with new product launches expected to enhance revenue streams [10][12] Future Outlook - Sanofi's robust pipeline in oncology and consumer healthcare, along with its innovative strategies, positions the company favorably for future growth [12]

Investment Rating - The investment rating for the company is "Buy" (maintained) [5] Core Views - The company is expected to achieve steady growth in core products in 2024, with new drugs potentially providing flexibility in revenue generation [5][7] - The company reported a total revenue of 9.108 billion RMB in 2024, representing a year-on-year growth of 16.5%, with drug sales contributing 8.928 billion RMB, also up by 16.8% [7] - The net profit attributable to shareholders reached 2.09 billion RMB, marking a significant increase of 34.9% year-on-year [7] - Key products such as Tevizo and Mandi are experiencing robust growth, with Tevizo sales projected at 5.06 billion RMB in 2024, reflecting a 20.4% increase [7] - The company has a promising pipeline of innovative drugs, including the PD1/VEGF dual antibody, which shows potential for high returns from overseas markets [7] Financial Summary - Revenue projections for the company are as follows: 10.102 billion RMB in 2025, 11.164 billion RMB in 2026, and 12.430 billion RMB in 2027, with growth rates of 10.9%, 10.5%, and 11.3% respectively [6][8] - The net profit attributable to shareholders is forecasted to be 2.343 billion RMB in 2025, with a growth rate of 12.1% [6][8] - The company's price-to-earnings ratio (P/E) is projected to be 12.42 in 2025, decreasing to 9.68 by 2027 [6][8] - The company aims for a target market value of 40 billion RMB, supported by steady growth in core business and innovative products [7]

Investment Rating - The investment rating for the company is "Outperform the Market" [6][20]. Core Insights - The company has demonstrated robust revenue growth, with projected revenue of 9.11 billion yuan in 2024, representing a 16.5% increase. Gross profit is expected to reach 7.83 billion yuan, up 17.9%, with a gross margin improvement to 86% [1][9]. - The core product, Tebentafusp, achieved sales of 5.062 billion yuan, a 20.4% increase, capturing 66.6% of the Chinese market for thrombocytopenia treatment. The company has also successfully renewed its medical insurance contracts [2][12]. - The innovative pipeline is progressing rapidly, with the dual antibody product 707 showing promising clinical results in lung cancer and colorectal cancer trials, achieving an overall response rate (ORR) of 70.8% in monotherapy for PD-L1 positive NSCLC [3][14][17]. Financial Performance and Projections - The company is expected to achieve a net profit of 2.09 billion yuan in 2024, a 34.9% increase, with adjusted operating net profit reaching 2.32 billion yuan, up 18.8% [1][9]. - R&D expenses are projected to rise significantly to 1.327 billion yuan in 2024, reflecting a 66.9% increase, indicating a strong commitment to innovation [1][9]. - The financial forecast for 2025-2027 includes net profits of 2.39 billion yuan, 2.71 billion yuan, and 3.07 billion yuan, respectively, with year-on-year growth rates of 14.1%, 13.7%, and 13.1% [4][20]. Market Position and Strategy - The company is actively expanding its commercial footprint through strategic collaborations in various therapeutic areas, including nephrology, oncology, and metabolic diseases. In 2024, three new drugs are expected to be approved, and four new drug applications are under review [15][19]. - The dual antibody 707 is positioned favorably in the market, with ongoing clinical trials and a strong potential for international licensing opportunities [19][20].

Core Viewpoint - Company maintains adjusted net profit forecast for 2025 at 2.407 billion and introduces 2026 adjusted net profit at 2.602 billion, with current stock price corresponding to 12.7/11.5 times adjusted P/E for 2025/2026 [1] Financial Performance - Company reported 2024 revenue of 9.108 billion, a year-on-year increase of 16.5%; net profit attributable to shareholders was 2.090 billion, up 34.9%; adjusted operating net profit reached 2.319 billion, reflecting an 18.8% increase, outperforming expectations due to stable growth of core products and increased income from joint ventures [2] Core Product Growth - Core product Terbinafine achieved revenue of 5.062 billion in 2024, a year-on-year increase of 20.4%, accounting for 55.6% of total revenue; EPO market leader with 42% share from Yibiao and Saibo, generating 1.018 billion, up 8.3%; Mandib achieved revenue of 1.337 billion, an 18.9% increase, with new foam agent enhancing competitiveness [3] R&D Pipeline - Company received approval for three new drugs including Aicoparib suspension in 2024 and submitted NDA for four products; R&D pipeline includes over 30 products across various therapeutic areas, with 10 in phase III clinical trials; 707 (anti-VEGF/PD-1 dual antibody) has entered phase III clinical trials, showing potential for BIC [4] Business Development Collaborations - Company completed several license-in collaborations in 2024, including partnerships for GLP-1, oral paclitaxel, and others, which are expected to provide revenue increments; anticipation for more business development collaborations, especially license-out projects, to enhance performance [5]

Investment Rating - The investment rating for the company is "Buy" (maintained) [3][9] Core Insights - The company reported a revenue of 9.11 billion yuan for 2024, representing a year-over-year growth of 16.5%. The net profit attributable to shareholders was 2.09 billion yuan, with a year-over-year increase of 34.9% [4][6] - The company is expected to achieve revenues of 10.20 billion yuan, 11.49 billion yuan, and 13.15 billion yuan for 2025, 2026, and 2027 respectively, with growth rates of 12%, 13%, and 14% [6][8] - The adjusted net profit for 2024 was 2.32 billion yuan, exceeding expectations with a year-over-year growth of 18.8% [4][6] Financial Performance Summary - The company’s total revenue for 2023 was 7.84 billion yuan, with a growth rate of 14% year-over-year [3] - The net profit attributable to shareholders for 2023 was 1.55 billion yuan, showing a decline of 19% year-over-year [3] - Earnings per share (EPS) for 2023 was 0.65 yuan, projected to increase to 0.87 yuan in 2024 and further to 1.26 yuan by 2027 [3][8] Pipeline and Market Potential - The company has several upcoming product approvals, including a license-in product for gastric cancer and new indications for existing drugs, which are expected to drive future growth [6] - The company is focusing on expanding its international market presence, particularly with its dual-antibody products [6]