Core Viewpoint - The company, Weili Zhibo, has successfully positioned itself in the T-cell engager (TCE) segment of the biotech industry, which is less mainstream compared to antibody-drug conjugates (ADC), and aims to create real value in innovative drugs rather than chasing trends [5][6][7]. Company Overview - Weili Zhibo completed its IPO on July 25, 2023, becoming the first TCE-focused company listed in China, with significant market interest reflected in a subscription rate of 3494.8 times for retail investors and 40.8 times for institutional investors [5][6]. - The company has a pipeline of six innovative drug candidates, with the closest to market being LBL-024, targeting advanced neuroendocrine carcinoma, expected to submit for approval in Q3 2026 [10][12]. Market Positioning - The TCE technology is gaining traction in the immunotherapy space, particularly for blood cancers, but remains less recognized than ADCs. The company believes that TCEs and ADCs serve different purposes and can coexist in the market [7][8]. - The first TCE drug to surpass $1 billion in sales is Amgen's Blincyto, which highlights the potential of this segment despite the challenges faced by other companies in the field [8]. Clinical Development - Weili Zhibo's LBL-034 has shown promising clinical trial results, achieving a 90% objective response rate in patients with relapsed/refractory multiple myeloma, outperforming the only approved competitor [9][10]. - The company plans to expand its focus from niche indications like neuroendocrine carcinoma to larger cancer types, including small cell lung cancer and non-small cell lung cancer, to create a broad-spectrum oncology portfolio [12][14]. Financial Strategy - The company currently has approximately 2 billion RMB in funds, sufficient to support its R&D plans for the next 4 to 5 years without immediate need for additional financing [16][17]. - Weili Zhibo has engaged in a global licensing agreement with Dianthus Therapeutics, which could yield up to $38 million in upfront payments and over $1 billion in total deal value, indicating a strategic focus on business development [16]. Industry Outlook - The innovative drug market is experiencing a shift towards rational investment, with companies focusing on clinical data and development pipelines rather than speculative trends [6][18]. - The domestic market for innovative drugs in China is expected to grow significantly over the next decade, providing a supportive environment for companies like Weili Zhibo, even amid international challenges [17].

Core Insights - The company has initiated a Phase II clinical trial for LBL-024, a PD-L1/4-1BB bispecific antibody, for first-line treatment of biliary tract cancer, marking significant progress in expanding the indication for this core product [1] - LBL-024 is the first targeted therapy for 4-1BB receptor to reach the registered clinical stage globally, with potential to become the first approved drug for advanced extra-pulmonary neuroendocrine carcinoma [1] - The drug utilizes the proprietary X-bodyTM platform with an optimal 2:2 structural design, aiming to enhance T-cell activation and synergistically eliminate tumors, showing greater cancer treatment potential compared to PD-1/L1 inhibitors [1] Regulatory Approvals - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial [2] - In October 2024, LBL-024 was granted Breakthrough Therapy Designation (BTD) by NMPA for the treatment of advanced extra-pulmonary neuroendocrine carcinoma [2] - In November 2024, the U.S. Food and Drug Administration (FDA) designated LBL-024 as an Orphan Drug (ODD) for neuroendocrine carcinoma [2]

Core Insights - The company announced the successful administration of the first patient in a Phase II clinical trial for LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB for the first-line treatment of biliary cancer, indicating efficient progress in expanding the product's indications [1] - The Phase II clinical study, led by Professor Qian Jian from Zhongshan Hospital affiliated with Fudan University, is being conducted at multiple hospitals across the country to evaluate the efficacy and safety of LBL-024 in treating advanced biliary cancer [1] - LBL-024 is the first targeted therapy for the 4-1BB receptor to reach the registered clinical stage for treating extra-pulmonary neuroendocrine cancer, with potential to become the first approved drug for this indication [1] Regulatory Approvals - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial [2] - In October 2024, the company obtained Breakthrough Therapy Designation (BTD) from NMPA for LBL-024 as a treatment for post-line advanced extra-pulmonary neuroendocrine cancer [2] - In November 2024, the company received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for LBL-024 in treating neuroendocrine cancer [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]