Core Viewpoint - The approval of LBL-047 by the FDA marks a significant milestone for the company, indicating its potential as a first-in-class therapeutic option targeting both BDCA2 and TACI, which currently has no approved or clinical counterparts globally [1]. Company Overview - The company, Valiant Biopharma-B (09887), saw its stock rise nearly 4%, trading at 66 HKD with a transaction volume of 23.94 million HKD [1]. - Valiant Biopharma currently has 14 drug candidates, with 6 in clinical stages, including 1 core product and 3 major products [1]. Product Details - LBL-047 is a bispecific fusion protein composed of a humanized anti-BDCA2 antibody and a modified TACI extracellular domain, showcasing its unique mechanism of action [1]. - The core product, LBL-024, is a PD-L1 and 4-1BB bispecific antibody currently in registration clinical stages, being evaluated for its efficacy against various advanced cancers, including small cell lung cancer and non-small cell lung cancer [1].

近期，百奥赛图在全球创新药产业链上的存在感愈发强烈。进入9月，公司接连发布三项合作消息，涵 盖核酸药物递送、ADC研发与双抗ADC合作项目进展，充分展现了其"双业务线"战略的纵深布局与国 际竞争力。 核酸递送新尝试：携手默克推进抗体偶联LNP 在与默克（Merck）的最新合作中，百奥赛图基于RenMice®平台提供全人抗体，默克将评估其在抗体 偶联脂质纳米颗粒（LNP）中的应用潜力。LNP是当下核酸药物领域的关键技术，而通过抗体偶联提升 递送精准度，可能为下一代核酸疗法打开新空间。 该协议赋予默克独家选择权，一旦行权，百奥赛图将获得费用、里程碑付款以及销售分成。这一合作不 仅验证了百奥赛图全人抗体平台的广泛适配性，也突显其在新兴治疗模式中的应用前景。 ADC管线加速：Tubulis签署抗体许可协议 另一边，德国生物技术公司Tubulis宣布引入百奥赛图自主开发的全人抗体，用于新一代抗体偶联药物 （ADC）的研发。这一分子同样源自RenMice®平台，具备高亲和力和良好的开发潜力。 双方合作的推进意味着百奥赛图的抗体资产不仅能提供研究阶段的支持，更能真正进入后续临床开发与 商业化通道。公司将在协议下获得首付款、 ...

Core Viewpoint - The company held a successful half-year performance briefing on September 19, 2025, with full interaction with investors, addressing various inquiries regarding stock issuance, project updates, and financial performance [1][2]. Group 1: Stock Issuance and Financial Performance - The company has submitted a registration application to the China Securities Regulatory Commission for a stock issuance to specific investors, following the Shanghai Stock Exchange's review [1][2]. - The pricing for the stock issuance will be no less than 80% of the average trading price over the 20 trading days prior to the pricing date [1][2]. - The company reported a significant profit decline in the first half of 2025, primarily due to non-recurring gains from asset disposals in the previous year, which amounted to 156 million [2][3]. Group 2: Project Updates - The trans-aconitic acid green bio-manufacturing project commenced production on May 29, 2025, marking a significant step towards industrialization [1]. - The company has over 60 biological pesticide products in production and sales, with three innovative biological pesticides currently under registration [1][2]. - The trans-aconitic acid pesticide formulation is in the testing phase, with plans to submit registration materials in the first quarter of 2026 [1][2]. Group 3: R&D and Product Development - The company has three I-class innovative drugs in clinical trials: TRN-157 for chronic obstructive pulmonary disease in Phase II, CIGB-814 for rheumatoid arthritis in Phase I, and CMS-203, a PDE5 inhibitor for male erectile dysfunction in Phase II [2][3]. - The company is focusing on enhancing operational efficiency and profitability to improve its investment value amidst a competitive pharmaceutical market [2][3].

Core Insights - The Chinese innovative drug sector is rapidly rising, with over 40% of BD transactions from multinational pharmaceutical companies involving Chinese biotech firms as of May 2023, compared to less than 5% four years ago [1] - Despite political tensions, the demand for innovative drugs continues to grow, driven by multinational companies facing patent cliffs and declining R&D efficiency [3][4] - Companies like Baiaosaitou are redefining the globalization path of Chinese innovative drugs, positioning themselves as essential infrastructure for global drug development [1][12] Industry Trends - The current wave of BD collaborations is supported by two main factors: the impending loss of patent protection for over $1 trillion in blockbuster drugs and the need for improved innovation returns [3][4] - Major pharmaceutical companies are increasingly focusing on efficiency and are actively seeking partnerships in China, recognizing the speed and quality of Chinese innovative drugs [7] - The trend of Chinese companies transitioning from "license in" to "license out" signifies a shift towards a new model of drug development, emphasizing platform-based approaches [18] Company Performance - Baiaosaitou achieved profitability in 2024, with further improvements in profit quality in the first half of 2025, demonstrating the sustainability of its innovation capabilities [2] - The company has established over 280 drug collaboration agreements, with a significant increase in new orders, leading to a revenue of 621 million yuan in the first half of 2025, a 51.5% year-on-year increase [8] - Baiaosaitou's unique technology platforms, including gene editing and humanized mouse models, enable it to efficiently support drug discovery and development, significantly shortening the drug development cycle [11][12] Technological Advancements - Baiaosaitou's innovative platforms, such as the RenMab and RenLite, allow for the rapid discovery and development of human antibodies, addressing critical challenges in drug development [11][17] - The integration of AI and automation with its extensive antibody library enhances the efficiency of drug discovery processes, positioning Baiaosaitou as a key player in the global antibody drug development landscape [17] - The company is expanding its capabilities to include diverse therapeutic formats, such as bispecific antibodies and antibody-drug conjugates, to meet evolving market demands [15][17] Future Outlook - The emergence of the "antibody+" era indicates a shift towards more complex therapeutic modalities, providing opportunities for companies like Baiaosaitou to leverage their technological advancements [13][14] - As global collaborations deepen, Baiaosaitou is poised to become an indispensable partner in the antibody drug development process, driving innovation and growth in the industry [12][18] - The ongoing transformation in the Chinese pharmaceutical landscape reflects a broader trend of redefining value chains through technological platforms and global market engagement [18]

Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 香港交易及結算所有限公司及香港聯合交易所有限公司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 聲 明，並 明 確 表 示，概 不 對 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。 （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 自願公告 LBL-047取得美國FDA的IND批 准 本公告由南京 維 立志博生物科技股份有限公司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）自 願 作 出，以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本 公 司 欣 然 宣 布，美 國 食 品 藥 品 監 督 管 理 局（「美 國FDA」）已 於2025年9月19日 批 准其自主研發藥物LBL-047的新藥臨床試驗（「IND」）申 請。LBL-047是一種由人源 化抗血液樹突狀細胞抗原2（BDCA2）抗體及經改 ...

Core Insights - The event "Biomanufacturing Leading Future Industrial Pattern" held in Changfeng, Hefei, is part of the 2025 World Manufacturing Conference, focusing on biomanufacturing as a key industry [1][3] - The Hefei Biomanufacturing Provincial Future Industry Pilot Zone is the only pilot zone in Anhui Province dedicated to life sciences [1][3] Group 1: Event Overview - The event emphasized the importance of biomanufacturing, discussing key common links and hot subfields, and aimed to promote industrial integration and cluster development [3] - The Hefei Biomanufacturing Provincial Future Industry Pilot Zone was officially approved in October 2024, with plans for the Hefei Synthetic Biomanufacturing Industrial Park [3] Group 2: Industry Development - The pilot zone has made significant progress in its first year, with major projects like the AI-driven biomanufacturing R&D base and microbial agent technology application base set to be completed soon [3] - The pilot zone currently hosts two listed biomanufacturing companies, with one more planning to go public next year, and five key enterprises are expected to achieve a combined output value of 4 billion yuan in 2024 [3][4] Group 3: Regional Focus - Anhui Province has established a comprehensive biomanufacturing industry system covering six sectors, with biopharmaceuticals, bio-foods, and bio-energy clusters each exceeding 10 billion yuan in scale [4] - Changfeng County aims to reach a biomanufacturing output value of 15 billion yuan by 2027 and over 30 billion yuan by 2030, with plans to establish four provincial-level innovation platforms and cultivate ten leading enterprises [5][7]

格隆汇9月22日｜永泰生物(6978.HK)盘中一度跌超16%，报3.98港元。消息面上，公司建议5供1供股集 资，供股价每股2.5港元，集资最多3.08亿港元。供股价较停牌前4.78港元，折让47.7%。供股所得款项 净额，约54%用作EAL临床试验；约24%用作扩大EAL其他临床适应症的研发开支；及约22%用作一般 营运资金。 ...

一家生物制药企业的日常，如何与亿万人的健康息息相关？早晨9点的实验室，正在发生什么？下午4点 的生产线，又如何运转？环球网独家纪实《智飞一日》，用镜头为您呈现智飞生物重庆、合肥、北京三 大研产基地，见证生物制药背后的科技创新与人性温度。镜头之下，是平凡的一天；镜头之外，是不平 凡的使命，致敬每一份为人类健康而努力的坚守。 来源：环球网 ...

Core Viewpoint - Connaissance-B (02162) has initiated its first Phase III clinical trial for CM336, a dual antibody drug, which has led to a significant increase in its stock price, reflecting positive market sentiment towards the company's progress in drug development [1] Company Summary - Connaissance-B's stock price rose over 5% during trading, closing at 75.4 HKD with a trading volume of 87.53 million HKD [1] - The Phase III trial for CM336 is a randomized, open-label, multi-center study involving 280 patients, aimed at evaluating the drug's efficacy and safety in treating relapsed or refractory multiple myeloma (R/R MM) patients who have previously undergone at least two lines of treatment [1] - The primary endpoint of the study is progression-free survival (PFS) [1] Clinical Trial Summary - CM336 has previously completed a Phase I/II study for R/R MM, where 23 patients were evaluated for efficacy [1] - Results from the earlier study indicated that at a median follow-up of 12.1 months, the objective response rates (ORR) for the ≤5 mg, 20-40 mg, and 80-160 mg groups were 17%, 71%, and 80% respectively [1] - The rates of strict complete response or complete response among patients in these groups were 17%, 71%, and 60% respectively [1]

Core Insights - A strategic collaboration has been established among InSilico Medicine, Maiwei Biotech, and Haoyuan Pharmaceutical to develop a new library of ADC compounds targeting hundreds of antigens, aiming to accelerate the industrialization of innovative ADC drugs [1][2][3] Group 1: Collaboration Details - The partnership is based on the principles of complementary advantages, resource sharing, collaborative innovation, and mutual benefits [1] - Maiwei Biotech will provide access to hundreds of monoclonal and multi-antibody combinations along with its proprietary ADC technology platform, covering various disease areas such as tumors and autoimmune diseases [1][2] - InSilico Medicine will leverage its Pharma.AI platform to design innovative payload-linkers based on disease mechanisms and target characteristics, showcasing the advantages of AI in drug development [2] Group 2: Industry Impact - This collaboration represents a significant innovation breakthrough in China's biopharmaceutical industry within the ADC drug sector, integrating AI technology with traditional drug development [2] - The partnership aims to create a complete value chain for ADC drug development, enhancing efficiency by shortening the molecular optimization process that traditionally takes years [2] - The collaboration is expected to provide more effective and safer treatment options for global patients by accelerating the development of ADC drugs [3]