贝达药业股份有限公司（以下简称"公司"）今日接到股东宁波凯铭投资管理合伙企业 （有限合伙）（以下简称"凯铭投资"）函告，获悉凯铭投资持有本公司的部分股份发生质 押变动，现将具体情况公告如下： 一、股东股份质押基本情况 证券代码：300558 证券简称：贝达药业 公告编号：2025-093 贝达药业股份有限公司 关于股东股份质押变动的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 1、凯铭投资股份解除质押情况 | 股东 | 是否为控股股东或 第一大股东及其 | 本次解除质押 | 占其所持 | 占公司 总股本 | 起始日 | 解除日期 | 质权人 | | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | 一致行动人 | 股份数量（股） | 股份比例 | 比例 | | | | | 凯铭投资 | 是 | 4,760,000 | 5.95% | 1.13% | 2024/3/20 | 2025/12/29 | 云南国际信托有限公司 | | 凯铭投资 | 是 | 1,990,000 | 2.49% | 0. ...

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for 19 companies, including Shimai Pharmaceutical, which must clarify the progress of state-owned shareholder management procedures and other matters related to its overseas listing application [1]. Group 1: Company Requirements - Shimai Pharmaceutical needs to provide details on the progress of state-owned shareholders fulfilling state-owned stock identification and management procedures [2]. - The company must explain the pricing basis and reasons for price differences in past capital increases and share transfers, and confirm the legality and compliance of its establishment and share changes [3]. - It is required to clarify whether the shares held by shareholders participating in the "full circulation" are subject to pledges, freezes, or other rights defects [4]. Group 2: Financial Performance - Shimai Pharmaceutical has not generated any drug sales revenue or milestone payments, with total other income of approximately 14.65 million yuan, 6.62 million yuan, and 2.28 million yuan for 2023, 2024, and the first half of 2025, respectively [4]. - The company reported losses of 74.94 million yuan, 59.90 million yuan, and 25.42 million yuan for the years 2023, 2024, and the first half of 2025, with cumulative losses exceeding 160 million yuan [5]. - The primary reason for ongoing losses is the lack of commercialized products, with income mainly from government subsidies and investment returns, which are insufficient to cover high R&D and operational costs [5]. Group 3: R&D Expenditure - R&D expenses for the company were 76.11 million yuan, 53.38 million yuan, and 22.39 million yuan for 2023, 2024, and the first half of 2025, respectively, indicating a significant decline in R&D investment [6]. - The R&D expenditure for the core product SMET12 decreased by 73.7% in the first half of 2025 compared to the same period in 2024, raising concerns about the development of core products [6]. Group 4: Cash Flow and Financing - As of June 30, 2025, the company's cash and cash equivalents were only 85.74 million yuan, while the average annual R&D expenditure was around 60 million yuan [7]. - By September 30, 2025, cash and cash equivalents sharply declined to 5.71 million yuan, indicating a rapid depletion of funds [8]. - The company has completed three rounds of financing, with a post-Series C valuation of 2.23 billion yuan, supported by investors such as Betta Pharmaceuticals and Tigermed [9]. Group 5: Market Potential - The global TCE market is projected to reach approximately $3 billion by 2024, with a compound annual growth rate (CAGR) of 40% expected to grow to $121.1 billion by 2035 [10]. - The Chinese TCE market is anticipated to reach 700 million yuan by 2024, with a CAGR of 63.8% expected to grow to 159.6 billion yuan by 2035 [10]. Group 6: Shareholder Structure and Future Plans - The company's actual controller, Xiao Zuoxiang, holds 53.2% of the shares, making him the controlling shareholder, while Betta Pharmaceuticals holds 4.75% through its subsidiary [11]. - The company plans to use the funds raised from its Hong Kong listing primarily for clinical development of core products, optimization of technology platforms, new product development, and operational funding [11].

Core Viewpoint - The China Securities Regulatory Commission has issued supplementary material requirements for 19 companies, including Shimai Pharmaceutical, which must clarify the progress of state-owned shareholders in fulfilling state asset management procedures [1][2]. Group 1: Company Overview - Shimai Pharmaceutical was established in 2017 and focuses on the development of T-cell engagers (TCEs), with four clinical-stage candidates: DNV3, SMET12, CMD011, and CMDE005 [2]. - The company has received three rounds of financing, with a post-Series C valuation of 2.23 billion RMB, driven by investor optimism regarding the TCE therapy market [8]. Group 2: Financial Performance - The company reported no drug sales or milestone payments during the reporting period, with other income of approximately 14.65 million RMB in 2023, 6.62 million RMB in 2024, and 2.28 million RMB in the first half of 2025, primarily from government subsidies and investment income [3]. - Shimai Pharmaceutical's losses were 74.94 million RMB in 2023, 59.90 million RMB in 2024, and 25.42 million RMB in the first half of 2025, totaling over 160 million RMB in cumulative losses [3][4]. - The company has indicated that it may never achieve or maintain profitability, as it has not yet commercialized any products [3]. Group 3: Research and Development - Research and development expenses were 76.11 million RMB in 2023, 53.38 million RMB in 2024, and 22.39 million RMB in the first half of 2025, showing a significant decline that raises concerns about the development of core products [4][5]. - The R&D spending for the core product SMET12 decreased by 73.7% to 2.14 million RMB in the first half of 2025 compared to the same period in 2024 [5]. Group 4: Market Potential - The global TCE market is projected to reach approximately 3 billion USD by 2024, with a compound annual growth rate of 40% expected to grow to 121.1 billion USD by 2035 [8]. - The Chinese TCE market is expected to reach 700 million RMB by 2024, with a compound annual growth rate of 63.8% projected to grow to 159.6 billion RMB by 2035 [8]. Group 5: Funding and Cash Flow - The company has utilized 62.32 million RMB and 45.23 million RMB for financial investments in 2024 and the first half of 2025, respectively, despite ongoing losses [6]. - As of June 30, 2025, the company's cash and cash equivalents were only 5.71 million RMB, a significant decrease from 85.74 million RMB just three months prior [7].

Investment Rating - The report does not explicitly state an investment rating for the biopharmaceutical industry, but it suggests a positive outlook based on upcoming catalysts and potential drug approvals. Core Insights - The biopharmaceutical sector is expected to see significant developments in 2026, with multiple domestic drugs anticipated to report key clinical data. This includes drugs from companies like Betta Pharmaceuticals, Hutchison China MediTech, and CanSino Biologics, which are expected to read out critical clinical data in 2026 [3][21]. - The report emphasizes that the long-term theme for the innovative drug sector is international expansion, with several sub-themes to focus on, including overseas business development (BD) licensing, key clinical trials, and unexpected overseas sales growth [3][18]. Summary by Sections Weekly New Drug Market Review - From December 22 to December 28, 2025, the top five gainers in the new drug sector were Dongyao Pharmaceutical (+23.15%), Beihai Kangcheng (+19.27%), Junshengtai (+16.41%), Shiyao Group (+6.95%), and Ailis (+5.78%). The top five losers were Gakos (-16.11%), Jiahe Biotech (-10.29%), Laika Pharmaceuticals (-9.33%), Yunding Xinyao (-8.98%), and Yongtai Biotech (-6.94%) [1][14]. Weekly Focused Stocks - The report suggests focusing on several stocks with high overseas expansion potential, including: 1. Companies with MNC certification and high overseas volume certainty: Sanofi, United Pharmaceuticals, and Kelun-Biotech. 2. Companies with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and InnoCare Pharma. 3. Potential heavyweights for overseas MNC licensing: Junshi Biosciences, Shiyao Group, and Yifang Biotech. 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat loss and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][18]. Weekly New Drug Approval & Acceptance Status - This week, 23 new drug or new indication applications were approved in China, and 10 new drug or new indication applications were accepted [4][19]. Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 99 new drug clinical applications were approved, and 64 new drug clinical applications were accepted [5][24]. Key Domestic Market Events - Notable events include: 1. Xiansheng Zhaoming announced a global exclusive licensing agreement with Ipsen for an ADC drug, potentially worth up to $1.06 billion. 2. He Yu Pharmaceuticals received approval for its CSF-1R selective small molecule inhibitor. 3. Tongyi Pharmaceuticals announced a licensing agreement for a peptide conjugate drug for prostate cancer, with potential payments totaling around $2 billion [10]. Key Overseas Market Events - Significant overseas events include: 1. Novo Nordisk received FDA approval for a 25mg oral semaglutide tablet for weight loss. 2. Sanofi announced a cash acquisition agreement for Dynavax Technologies Corporation, valued at approximately $2.2 billion. 3. Agios Pharmaceuticals announced FDA approval for an oral PK activator for treating α or β thalassemia in adult patients [11].

本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 证券代码：300558 证券简称：贝达药业 公告编号：2025-092 贝达药业股份有限公司 关于股东股份质押变动的公告 贝达药业股份有限公司（以下简称"公司"）今日接到股东宁波凯铭投资管理合伙企业 （有限合伙）（以下简称"凯铭投资"）函告，获悉凯铭投资持有本公司的部分股份发生质 押变动，现将具体情况公告如下： 一、股东股份质押基本情况 1、凯铭投资股份新增质押情况 | | 是否为控 | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东 | 股股东或 | 本次质押 | 占其所 | 占公司 | 是否为 | 是否为 | 质押 | 质押 | | 质押 | | 名称 | 第一大股 | 数量 | 持股份 | 总股本 | 限售股 | 补充质押 | 起始日 | 到期日 | 质权人 | 用途 | | | 东及其一 | （股） | 比例 | 比例 | | | | | | | | | 致行动人 | | ...

Core Viewpoint - Hanse Aitai Biopharmaceutical Technology (Wuhan) Co., Ltd. successfully listed on the Hong Kong Stock Exchange, marking it as the second company from Wuhan to go public under the HKEX's 18A biotech rules. The company focuses on developing innovative drugs for cancer and autoimmune diseases, addressing unmet medical needs in these areas [3][4]. Group 1: IPO Details - Hanse Aitai issued 18.321 million H-shares at an offering price of HKD 32 per share, raising a total of HKD 586 million, with a market capitalization of nearly HKD 4.4 billion at issuance [3]. - On its first trading day, the opening price was HKD 28.9, and the latest market capitalization was HKD 3 billion [3]. - The company has completed three rounds of financing prior to the IPO, totaling approximately RMB 154 million, with major investors including Betta Pharmaceuticals and Longpan Investment [4]. Group 2: Product Pipeline and R&D Focus - The core product, HX009, is the world's only PD-1/SIRPα dual-function antibody fusion protein, currently in Phase II clinical trials in China after completing Phase I trials in China and Australia [4][20]. - Another innovative product, HX044, has initiated Phase I clinical trials for advanced solid tumors in both China and Australia [4][21]. - The company plans to allocate approximately 35% of the raised funds to advance HX009, 33% to develop HX301 and HX044, and 5% for commercialization preparations [4]. Group 3: Founder's Background and Company Development - Founder Zhang Faming, who has a strong academic and professional background in biochemistry and pharmaceutical development, has previously founded and sold successful biotech companies [10][11]. - Hanse Aitai was established in 2014 and has since focused on developing next-generation immunotherapies, particularly targeting the limitations of existing PD-1 therapies [15][17]. - The company has built a robust R&D team, integrating expertise from various fields to enhance its drug development capabilities [15][20]. Group 4: Market Context and Competitive Landscape - The global PD-1/PD-L1 antibody market is projected to reach USD 53.7 billion by 2024, with expectations to grow to USD 72.5 billion by 2030, highlighting the competitive nature of the immunotherapy sector [25]. - Hanse Aitai's dual-target design for HX044 aims to address the challenges of PD-1 resistance, positioning the company in a competitive landscape with several other firms pursuing similar therapeutic strategies [26][28]. - The company is one of the few globally to have two clinical-stage products targeting the SIRPα pathway, indicating significant long-term collaboration potential [28].

Investment Rating - The report maintains an investment rating of "Outperform" with a target of A [7] Core Insights - The report highlights the positive results from Takeda's new generation oral TYK2 inhibitor, zasocitinib (TAK-279), for treating moderate to severe plaque psoriasis, with over 50% of participants achieving skin clearance or nearly clear skin (PASI 90) at week 16, and about 30% achieving complete clearance (PASI 100) [3][4] - The report suggests that there are multiple catalysts expected in the sector, including academic conferences and data readouts, which could provide investment opportunities [2] - The report emphasizes the potential of other TYK2 inhibitors, particularly Eifang Biopharma's D-2570, which has shown promising phase 2 clinical data [4][22] Summary by Sections Weekly New Drug Market Review - From December 15 to December 21, 2025, the top five gainers in the new drug sector were: Yahu Medicine (+12.03%), Cloudtop New Medicine (+9.32%), Aidi Pharmaceutical (+9.06%), Shiyao Group (+7.05%), and Ailis (+3.94%). The top five losers were: Chuangsheng Group (-16.03%), Beihai Kangcheng (-12.33%), Kedi (-11.88%), WuXi AppTec (-11.15%), and Nuocheng Jianhua (-10.99%) [1][17] Weekly Focus on Recommended Stocks - The report recommends focusing on companies with high certainty for overseas expansion, such as Sanofi Biopharma, Lianbang Pharmaceutical, and Kelun Biotech. It also highlights companies with potential overseas data catalysts, including Betta Pharmaceuticals, Hutchison China MediTech, and Ying'en Biopharma [2][21] Weekly New Drug Industry Analysis - Takeda's phase 3 clinical trials for zasocitinib have shown consistent results with previous phase 2 trials, indicating strong data reliability. The report also notes the potential for TYK2 inhibitors in treating Crohn's disease and ulcerative colitis [3][4][22] Weekly New Drug Application Approval & Acceptance - No new drug or new indication applications were approved domestically this week, but 11 new drug or new indication applications were accepted [5][26] Weekly New Drug Clinical Application Approval & Acceptance - This week, 55 new drug clinical applications were approved, and 47 new drug clinical applications were accepted [11][28]

Core Viewpoint - He Yuan Bio became the first company to list on the Sci-Tech Innovation Board under the new standards for unprofitable companies, with its stock price initially surging by 354.3% from the issue price, although it has since experienced a market correction [1][3]. Company Overview - He Yuan Bio, established in 2006, focuses on innovative drug research and development, primarily generating revenue from non-core products like pharmaceutical excipients and research reagents, and has not yet achieved profitability [2]. Financial Performance - The company has reported continuous losses over the past three years, with losses of 144 million yuan, 187 million yuan, and 151 million yuan from 2022 to 2024, accumulating a total of 851 million yuan in unrecouped losses by the end of 2024 [3]. Product Development and Commercialization - The core product, recombinant human serum albumin injection (HY1001), has received regulatory approval and is positioned to replace traditional plasma-derived albumin, which is currently in high demand and largely imported [8][9]. - The company is actively building a sales team and forming partnerships with distributors to promote HY1001, which has already begun clinical applications [7][8]. Market Potential - The recombinant human serum albumin market in China is significant, with the company aiming to address the supply chain security issues and reduce reliance on imports through its innovative production method using rice [8][9]. - The company plans to expand the indications for HY1001, targeting a global multi-center clinical study to gain approvals in China, the U.S., and Europe [9]. Production Capacity and Strategy - He Yuan Bio is constructing an integrated production base to support the large-scale manufacturing of HY1001, with a designed capacity of 12 million doses per year, expected to be operational by 2026 [12][14]. - The production cost of HY1001 is anticipated to be significantly lower than that of traditional plasma-derived products, enhancing its market competitiveness [14]. Research and Development Focus - The company is committed to advancing other core projects and new drug development, focusing on new targets and concepts, while also enhancing its long-acting drug technology platform [14].

Group 1 - The core viewpoint of the news highlights a significant increase in the Shanghai Stock Exchange's Sci-Tech Innovation Board Innovative Drug Index, with a rise of 3.26% as of December 19, 2025, driven by strong performances from constituent stocks such as Chengdu Xian Dao (up 10.44%) and Yifang Bio (up 9.82%) [1] - The recent announcement by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security regarding the 2025 National Basic Medical Insurance Drug List includes 114 new drugs, of which 50 are innovative drugs, marking an 88% success rate, a 12 percentage point increase from 2024 [3] - The total R&D investment by innovative drug companies on the Sci-Tech Innovation Board reached a new high in the first three quarters of 2025, with a year-on-year increase of over 10% and an R&D intensity of 42%, significantly surpassing the overall level of A-shares [4] Group 2 - The collaboration between Innovent Biologics and Takeda Pharmaceutical regarding three innovative cancer drugs has been completed, with Innovent receiving a total upfront payment of $1.2 billion, including a strategic investment of $100 million, and potential milestone payments of up to $10.2 billion [5] - The CXO industry is entering a new high prosperity cycle, driven by external improvements, including overseas interest rate cuts and domestic recovery, with a focus on innovative drug companies benefiting from policy support and innovation upgrades [6] - The implementation of the "Medicare + Commercial Insurance" multi-layered medical security system is seen as a substantial breakthrough, with nearly 90% of new drugs approved by Sci-Tech Board biopharmaceutical companies included in the insurance list [3][4]

Core Viewpoint - Yifang Bio has established licensing agreements for two products, indicating a strategic move to expand its market presence and collaboration with other pharmaceutical companies [2] Group 1: Licensing Agreements - The company has two externally licensed products, including Befotalimab, for which it has reached a licensing cooperation with Betta Pharmaceuticals in the regions of mainland China, Hong Kong, and Taiwan [2] - For the product D-1553 (Gosorese), the company has granted an exclusive license to Zhengda Tianqing for the development, registration, production, and commercialization in mainland China [2]