Core Insights - The global biopharmaceutical industry is entering a rapid development phase, with accelerated technological iterations in cutting-edge fields such as antibody drugs, cell and gene therapy, and radiolabeled drug conjugates (RDC) [1] - Domestic policies are increasingly supporting innovative drug research and the standardization of quality control, presenting new opportunities for industry growth [1] Conference Highlights - Comprehensive coverage of five core biopharmaceutical areas: antibody/protein drugs, cell and gene therapy, nucleic acid drugs, peptide drugs, and RDC, addressing the entire "research and development - quality control" chain [2] - Over 25 top experts from industry and academia will participate, including R&D and quality control directors, renowned professors, and clinical department heads, fostering deep integration of industry, academia, and clinical practice [2] - All presentations will focus on core technologies and practical methods, utilizing real case studies to address technical challenges and solutions, enhancing attendees' ability to apply these methods in their work [2] Conference Details - The conference will take place from March 24 to 26, 2026, organized by the Instrument Information Network, with support from key laboratories and professional committees [4] Agenda Overview - The agenda includes specialized sessions on various topics such as antibody drug conjugation techniques, nucleic acid drug development, and quality control in cell and gene therapy, featuring presentations from leading experts in the field [5][6][7]

维迪西妥单抗是荣昌生物自主研发的中国首个原创抗体偶联(ADC)药物，以肿瘤表面的HER2蛋白为靶 点，能精准识别和杀伤肿瘤细胞，在治疗胃癌、尿路上皮癌、乳腺癌等肿瘤的临床试验中均取得了全球 领先的临床数据，是我国首个获得美国FDA、中国药监局突破性疗法双重认定的ADC药物。截至本公 告披露日，该药已相继获批用于治疗HER2过表达局部晚期或转移性胃癌、HER2过表达局部晚期或转移 性尿路上皮癌、HER2阳性且存在肝转移的晚期乳腺癌和HER2低表达且存在肝转移的乳腺癌四个适应 症。 智通财经APP讯，荣昌生物(688331.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的 《药品注册证书》，维迪西妥单抗(代号：RC48，商品名：爱地希®)用于治疗HER2低表达且存在肝转 移的乳腺癌的新适应症上市申请获得批准，这是维迪西妥单抗在国内获批的第四项适应症。 ...

Core Viewpoint - Rongchang Biopharmaceutical (688331.SH) has received approval from the National Medical Products Administration for the new indication of Vidixtimab (RC48, brand name: Aidiqi®) for the treatment of HER2 low-expressing breast cancer with liver metastasis, marking the fourth approved indication for this drug in China [1] Group 1 - The new indication is specifically for adult breast cancer patients who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy, and who have unresectable or metastatic HER2 low-expressing (IHC1+ or IHC2+/ISH-) breast cancer with liver metastasis [1]

转自：智通财经 【荣昌生物：维迪西妥单抗新增乳腺癌适应症获批】《科创板日报》23日讯，荣昌生物(688331.SH)公 告称，公司自主研发的注射用维迪西妥单抗(商品名：爱地希®)用于治疗HER2低表达且存在肝转移的乳 腺癌新适应症获国家药监局批准，成为该药在国内获批的第四项适应症。该适应症适用于既往接受过系 统治疗或辅助化疗后12个月内复发的不可切除或转移性HER2低表达成人乳腺癌患者。此次获批基于一 项Ⅲ期临床试验，结果显示其在目标人群中具有良好疗效与安全性。公司提示，药品商业化受政策、市 场及竞争等多重因素影响，存在不确定性。 ...

Core Viewpoint - Rongchang Biopharmaceutical has received approval from the National Medical Products Administration for the registration certificate of Vidisicimab (brand name: Aidiqi) for a new indication to treat HER2 low-expressing breast cancer with liver metastasis [1] Group 1 - Vidisicimab is now approved for its fourth indication in China [1] - The drug is indicated for adult patients with unresectable or metastatic HER2 low-expressing breast cancer (IHC 1+ or IHC 2+/ISH-) who have previously received at least one systemic treatment during the metastatic disease stage or have relapsed within 12 months after adjuvant chemotherapy [1]

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 申 請 版 本 的 內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 意 見，並 明 確 表 示 概 不 就 因 本 申 請 版 本 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。 Hangzhou Sciwind Biosciences Co., Ltd.* 杭州先為達生物科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 的申請版本 警 告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）與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。 本申請版本為草擬本，其內所載資料並不完整，亦可能會作出重大變動。 閣下閱覽本文件，即代表 閣下知悉、 接納並向本公司、其保薦人、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 登 記 前，本 公 ...

香 港 交 易 及 結 算 所 有 限 公 司、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 公 告 的 內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 意 見，並 明 確 表 示 概 不 就 因 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。 Hangzhou Sciwind Biosciences Co., Ltd.* (杭州先為達生物科技股份有限公司) （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） 警 告 本公告乃根據香港聯合交易所有限公司（「聯交所」）與證券及期貨事務監察委 員 會（「證監會」）的 要 求 而 刊 發，僅 用 作 向 香 港 公 眾 人 士 提 供 資 料。 閣 下 閱 覽 本 公 告，即 表 示 閣 下 知 悉、接 納 並 向 杭 州 先 為 達 生 物 科 技 股 份 有 限 公 司（「本公司」）、其 聯 席 保 薦 人、整 體 協 調 人、顧 問 或 包 ...

Core Viewpoint - The company, Fuhong Hanlin, has demonstrated robust growth in revenue and profit for three consecutive years, showcasing its strong profitability and high-quality growth capabilities, with a significant increase in R&D investment to support innovation [2]. Financial Performance - In 2025, the company achieved a revenue of 6.6666 billion yuan, representing a year-on-year growth of 16.5%, and a net profit of 827 million yuan. The total R&D investment reached 2.4919 billion yuan, up 35.4% year-on-year, with R&D investment as a percentage of profit at 2.3425 billion yuan, reflecting a growth of 26.2% [1]. Product Performance - The global product revenue for Fuhong Hanlin reached 5.7746 billion yuan in 2025, marking a 17.0% increase year-on-year. The core products, H药 (Hanshuozhuang) and 汉曲优 (Hanquyou), saw significant overseas revenue growth, with overseas product revenue exceeding 200 million yuan, doubling year-on-year [3][4]. Product Approvals and Market Reach - The company has 10 products approved in over 60 countries and regions globally, with 7 approved in China and 4 in the US and EU, benefiting over 1 million patients [5]. Core Product Sales - The core product H药 (Hanshuozhuang) generated global sales of 1.4926 billion yuan, a year-on-year increase of 13.7%. It has received approvals for first-line treatment of extensive-stage small cell lung cancer in multiple regions [7]. - 汉曲优 (Hanquyou) achieved global sales of 2.9645 billion yuan, up 5.5% year-on-year, and has been approved in over 50 countries [8]. Strategic Collaborations - The company has expanded its international registration and commercial cooperation, partnering with leading firms like Abbott and Sandoz for various products. It has received approvals for 27 clinical trial applications and 28 registration applications across more than 60 countries [11]. Innovation and Development - Fuhong Hanlin is enhancing its innovation platform, developing a multi-dimensional technology platform that includes next-generation IO platforms and AI-driven early-stage drug development. Several new drug candidates have received clinical trial approvals [14]. Future Prospects - The company is accelerating the development of its broad-spectrum anti-tumor PD-L1 ADC HLX43, which has shown promising results in early human studies and is expected to advance in various solid tumors [12].

Core Viewpoint - Tengsheng Bo Pharmaceutical-B (02137) reported a significant increase in revenue for the fiscal year ending December 31, 2025, amounting to RMB 18.605 million, compared to zero revenue in the same period last year. The company also narrowed its net loss to RMB 222.3 million, a 56.19% improvement year-on-year, with a loss per share of RMB 0.31 [2]. Financial Performance - The company's revenue increased due to payments received under a licensing and technology transfer agreement with Health Yuan Group (600380) [2]. - The net loss for the year was RMB 222.3 million, which represents a 56.19% reduction compared to the previous year [2]. - Earnings per share were reported at a loss of RMB 0.31 [2].

Investment Rating - The report does not provide a specific investment rating for Samsung Biologics [1] Core Insights - Samsung Biologics achieved a revenue growth of 30.3% in 2025, exceeding the previous guidance of 25-30%. The revenue growth guidance for 2026 is set at 15-20%, with potential upward revisions due to contributions from the U.S. facility and foreign exchange movements. The cumulative contract value surpassed USD 21.2 billion by the end of 2025 [2][4] - The company is focused on capacity expansion, particularly with the new U.S. facility and Plant 5 in Korea, which is expected to achieve high utilization rates once commercial production begins [2][4] - Samsung Biologics differentiates itself in the biologics manufacturing sector through superior quality, achieving a batch success rate of 99% compared to the industry average of 95%, and faster delivery times, completing plant construction in 24 months versus the industry average of 3-4 years [3][5] Summary by Sections 2025 Performance Review and 2026 Outlook - Samsung Biologics reported a revenue growth of 30.3% in 2025, with a cumulative contract value exceeding USD 21.2 billion. The company has set a revenue growth guidance of 15-20% for 2026, which may be revised upwards post-acquisition of the U.S. facility [2][4] Strategic Priorities for Plant 5 and the New U.S. Facility - The new U.S. facility is expected to start commercial production in Q2 2026, with plans for equipment upgrades and potential expansion from 60,000 liters to 200,000 liters. Plant 5 in Korea is on track to achieve over 80% utilization after ramp-up [2][4] Differentiation in Biologics Manufacturing - Samsung Biologics views Lonza and Fujifilm as key competitors and focuses on quality and speed as differentiators. The company employs a "cookie-cutter" model for plant construction, allowing for quicker market entry [3][5] Strategy and Outlook for ADCs and Other New Modalities - The company is well-positioned to capture market share in the ADC sector, with plans to offer end-to-end services starting in Q1 2027. The dedicated ADC facility is already under construction [5] U.S. vs. Korea Manufacturing Pricing - Manufacturing costs in the U.S. are higher due to labor costs being approximately double those in Korea. Samsung Biologics plans to pass some of these costs onto clients, anticipating lower margins for U.S. operations compared to its Korean facility [5] Long-Term Industry Capacity Oversupply - The company does not foresee a significant supply overhang in the industry for at least the next five years, citing stagnant productivity from large pharmaceutical companies and a continued trend towards outsourcing as key factors sustaining demand for CDMO services [2][5]