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 全部或任何部份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。 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 （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-024於一線治療膽道癌II期試驗的首例患者用藥 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，評 價 奧 帕 替 蘇 米 單 抗（PD-L1/4-1BB雙特異性抗體LBL-024）用 於一線治療膽道癌的II期 臨 床 試 驗 首 例 患 者 已 成 功 用 藥，標 誌 著 該 核 心 產 品 適 應 症 拓 展 高 ...

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。 南 京 維 立志博生物科技股份有限公司 （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 澄清公告 茲提述南京 維 立志博生物科技股份有限公司（「本公司」）日期為2025年10月16日 的兩份公告（「該等公告」），內容有關簽訂全球獨家許可協議。除另有界定者外， 本 公 告 所 用 詞 彙 與 該 等 公 告 所 界 定 者 具 有 相 同 涵 義。 本 公 司 謹 此 澄 清，與2025年10月16日下午八時四十八分在「披 露 易」網站刊登的 首份公告（「首份公告」）相 比，於2025年10月16日 下 午 十 時 三 十 六 分 在「披 露 易」 網站刊登的第二份公告（「經修訂公告」）第1頁 第4段 增 加 了 以 下 內 容： 「（包 括20百 萬 美 元 首 付 款、2025年第四季度支付的 ...

Core Insights - The company announced a global exclusive licensing agreement with Dianthus Therapeutics, Inc. to jointly advance the novel anti-BDCA2-TACI bispecific fusion protein LBL-047 [1] - LBL-047 has received IND approval for clinical trials in the United States and is under IND review in mainland China [1] Financial Terms - Dianthus will obtain exclusive rights for the research, development, and commercialization of LBL-047 outside Greater China [1] - The company will receive an upfront payment of up to $38 million, potential near-term milestone payments, and up to $1 billion in potential milestone payments related to clinical development, regulatory, and commercialization [1] - The company will also receive tiered royalties on net sales outside Greater China [1] Product Potential - LBL-047 targets BAFF/APRIL and BDCA2, showing therapeutic potential for various autoimmune diseases [1] - The drug is designed to reduce dosing frequency and improve patient compliance through glycosylation modifications and Fc region engineering [1]

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。 全球獨家許可協議的主要條款 根 據 全 球 獨 家 許 可 協 議，Dianthus將獲得在大中華區（包 括 中 國 內 地、中 國 香 港 特別行政區、中國澳門特別行政區及台灣）以外地區研發、生產及商業化LBL-047 的 全 球 獨 家 權 益。 根 據 全 球 獨 家 許 可 協 議，本 公 司 將 獲 得 最 高38百萬美元的首付款及潛在近期 里程碑付款（包 括20百 萬 美 元 首 付 款、2025年第四季度支付的5百萬美元及最高 13百 萬 美 元 的 潛 在 近 期 里 程 碑 付 款）及最高10億 美 元 的 潛 在 臨 床 開 發、監 管 及 商 業 化 里 程 碑 付 款。本 公 司 將 有 權 獲 得 大 中 華 區 以 外 ...

Core Viewpoint - The company has entered into a global exclusive licensing agreement with Dianthus Therapeutics to advance the clinical asset LBL-047, a novel anti-BDCA2-TACI bispecific fusion protein, which has received IND approval in the US and acceptance in mainland China [1][2]. Group 1: Licensing Agreement Details - The agreement grants Dianthus exclusive rights to develop, manufacture, and commercialize LBL-047 outside of Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan [1]. - The company will receive an upfront payment of up to $38 million, along with potential milestone payments totaling up to $1 billion related to clinical development, regulatory, and commercialization achievements [1]. - The company will also earn tiered royalties on net sales outside of Greater China, with rates ranging from single digits to low double digits [1]. Group 2: Strategic Importance - The collaboration with Dianthus, recognized for its leadership in developing transformative therapies for severe autoimmune diseases, is expected to enhance the company's commitment to advancing innovative drug candidates into clinical stages [2]. - The agreement aligns with the overall best interests of the company and its shareholders [2]. Group 3: Mechanism and Potential of LBL-047 - LBL-047 targets BAFF/APRIL and BDCA2, aiming to simultaneously inhibit the activity of plasmacytoid dendritic cells (pDC) and the differentiation and activation of B cells and plasma cells [3]. - The drug shows strong therapeutic potential for autoimmune diseases such as systemic lupus erythematosus (SLE), dermatomyositis, IgA nephropathy (IgAN), and Sjögren's syndrome [3]. - LBL-047 is designed with glycosylation modifications to enhance its efficacy and broaden its immunosuppressive effects, while Fc region modifications extend its half-life, reducing dosing frequency and improving patient compliance [3].

Core Viewpoint - The company has entered into a global exclusive licensing agreement with Dianthus Therapeutics, Inc. to jointly advance the clinical asset LBL-047, which has received IND approval in the U.S. and acceptance in China [1][2] Group 1: Licensing Agreement Details - The agreement grants Dianthus exclusive rights to develop, manufacture, and commercialize LBL-047 outside of Greater China [1] - The company will receive an upfront payment of up to $38 million, along with potential milestone payments totaling up to $1 billion for clinical development, regulatory, and commercialization milestones [1] - The company will also earn tiered royalties on net sales outside of Greater China, with rates ranging from single digits to low double digits [1] Group 2: Collaboration Significance - The collaboration with Dianthus, a recognized leader in transformative therapies for severe autoimmune diseases, is expected to enhance the company's commitment to advancing innovative drug candidates into clinical stages [2] - This partnership aligns with the overall best interests of the company and its shareholders [2] Group 3: Mechanism and Potential of LBL-047 - LBL-047 targets BAFF/APRIL and BDCA2 to simultaneously inhibit the activity of plasmacytoid dendritic cells (pDC) and the differentiation and activation of B cells and plasma cells [3] - The drug shows strong therapeutic potential for autoimmune diseases such as systemic lupus erythematosus (SLE), dermatomyositis, IgA nephropathy (IgAN), and Sjögren's syndrome [3] - LBL-047 is designed to have an extended half-life through Fc region modification, which may reduce dosing frequency and improve patient compliance [3]

Core Viewpoint - The company has entered into a global exclusive licensing agreement with Dianthus Therapeutics to advance the development of a novel dual-specificity fusion protein, LBL-047, aimed at treating severe autoimmune diseases [1][2] Group 1: Licensing Agreement Details - The agreement grants Dianthus exclusive rights to research, develop, and commercialize LBL-047 outside of Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan [1] - The company will receive an upfront payment of up to $38 million, along with potential milestone payments totaling up to $1 billion related to clinical development, regulatory, and commercialization achievements [1] - The company will also earn tiered royalties on net sales outside of Greater China, with rates ranging from single digits to low double digits [1] Group 2: Strategic Importance - The collaboration with Dianthus, recognized for its leadership and expertise in developing transformative therapies for severe autoimmune diseases, is expected to enhance the company's commitment to advancing innovative drug candidates into clinical stages [2] - The signing of the global exclusive licensing agreement aligns with the overall best interests of the company and its shareholders [2]

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。 Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 （於 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 內幕消息 就LBL-047與DIANTHUS簽訂全球獨家許可協議 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」）根據香港聯合交易所有限公司證券上市規則（「上市規則」）第13.09 條以及香港法例第571章證券及期貨條例第XIVA部 作 出。 本 公 司 欣 然 宣 布， 於2025年10月16日， 本 公 司 與Dianthus Therapeutics, Inc. （「Dianthus」，納 斯 達 克 代 碼：DNTH）簽訂全球獨家許可協議（「全球獨家許可協 議」），據 此，本 公 司 ...

Core Insights - The article discusses the rise of innovative drug companies in China, particularly in the field of cancer immunotherapy, as they shift from following trends to pioneering original research and development [1] Industry Overview - The Nobel Prize in Physiology or Medicine was awarded to three scientists for their discovery of regulatory T cells in the immune system, which opens new avenues for treating autoimmune diseases and cancer [2] - Immunotherapy has been a significant area of focus since the 1980s, with PD-1 inhibitors gaining prominence after their approval in 2014, demonstrating better efficacy and safety compared to traditional treatments [2] - The global sales of the PD-1 drug "K药" are projected to reach approximately $32.056 billion in 2024, maintaining its position as the world's top-selling drug [2] Company Focus - Weili Zhibo-B (维立志博-B) is a Chinese innovative drug company specializing in tumor immunotherapy, currently in clinical stages [2] - The company aims to address cancers that do not respond to existing PD-1 therapies, with a pipeline of 14 candidate drugs, four of which are in advanced clinical stages and have the potential to be first-in-class [4][6] - The company has developed a strategic focus on next-generation immunotherapy, emphasizing complex regulatory mechanisms to enhance immune system efficacy [4] Clinical Development - The PD-L1/4-1BB dual antibody (LBL-024) is the company's fastest progressing product, currently in Phase III clinical trials, showing promising results with a 75% objective response rate and a 92.3% disease control rate in a recent study [8][12] - The company is also advancing two CD3 TCE drugs, which have shown efficacy similar to CAR-T therapies but at a significantly lower cost, making them more accessible [13] Financing and Market Strategy - Weili Zhibo-B has successfully completed multiple funding rounds, raising a total of 1.084 billion yuan, with a significant increase in valuation from 40 million yuan in 2015 to 3.1 billion yuan in 2024 [10][11] - The company plans to leverage a light-asset strategy for commercialization, collaborating with CDMO partners for production while considering establishing its own facilities in the future [15] Future Outlook - The company aims to expand its indications from rare cancers to larger cancer types, with plans to submit a biological product license application for LBL-024 in the third quarter of 2026 [14] - The Chinese market for innovative drugs is expected to grow as economic development and consumer purchasing power increase, supported by favorable government policies [15]

Core Viewpoint - The article discusses the innovative strategies and advancements of Weilizhibo, a Chinese biopharmaceutical company focused on cancer immunotherapy, particularly in developing next-generation therapies that address limitations of existing PD-(L)1 treatments [4][5][6]. Group 1: Company Overview - Weilizhibo has 14 candidate innovative drugs, with 4 in the top three of global clinical progress, aiming to become first-in-class drugs [6][7]. - The company was founded by Kang Xiaoqiang and Lai Shoupeng in 2012, focusing on cancer immunotherapy after extensive research in the U.S. [8][9]. Group 2: Market Context - The global market for innovative drugs is rapidly evolving, with significant investment interest, particularly in the field of cancer immunotherapy [4]. - The PD-(L)1 inhibitors have shown a response rate of only about 20%, indicating a substantial unmet need in cancer treatment [6][10]. Group 3: Strategic Focus - Weilizhibo aims to address cancers that do not respond to PD-(L)1 therapies, focusing on alternative immune checkpoint inhibitors like LAG-3 and 4-1BB [10][11]. - The company has developed three core technology platforms: IO2.0, TCE, and ADC, which are expected to define the future of oncology [11][12]. Group 4: Clinical Progress - The PD-L1/4-1BB dual antibody (LBL-024) is currently in Phase III clinical trials and has shown promising results, with an objective response rate of 75% in a recent study [12][19]. - Weilizhibo's GPRC5D/CD3 dual antibody has completed Phase II trials and received orphan drug designation from the FDA, indicating its potential in treating multiple myeloma [19][20]. Group 5: Financial Strategy - Weilizhibo has successfully completed multiple funding rounds, raising a total of 1.084 billion yuan, with a significant increase in valuation from 40 million yuan in 2015 to 3.1 billion yuan in 2024 [15][16]. - The company strategically increased its IPO fundraising target to 189 million USD due to favorable market conditions, resulting in a successful listing on the Hong Kong Stock Exchange [16][17]. Group 6: Future Outlook - The company plans to expand its indications from rare cancers to larger cancer types, with a goal of submitting a biological license application by Q3 2026 [20][21]. - Weilizhibo intends to adopt a light-asset strategy for commercialization, collaborating with CDMOs for production while considering establishing its own facilities in the future [21][22].