透脑性口服TYK2抑制剂
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诺诚健华宣布年内第二笔BD授权 转让3款自免管线
Mei Ri Jing Ji Xin Wen· 2025-10-09 12:39
Core Viewpoint - The company, Innovent Biologics, announced a licensing agreement with Zenas for its core product, Orelabrutinib, in the field of multiple sclerosis and other non-oncological indications, marking its second business development (BD) deal of the year [1][2] Group 1: Licensing Agreement Details - Innovent's subsidiary, InnoCare, will receive up to $100 million in upfront and milestone payments from Zenas, along with 7 million shares of Zenas common stock, with the total potential deal value exceeding $2 billion [1][2] - The agreement allows Zenas to develop and commercialize Orelabrutinib globally for multiple sclerosis and other non-cancer treatments, while Innovent retains exclusive rights for oncology indications [2][4] Group 2: Product Pipeline and Market Potential - Orelabrutinib is currently approved for three indications in hematological malignancies in China and has initiated Phase III trials for primary progressive multiple sclerosis (PPMS) [2][5] - The new oral IL-17AA/AF inhibitor and the brain-penetrant oral TYK2 inhibitor are in preclinical stages, targeting autoimmune diseases, aligning with Zenas's focus [3][6] - The market for multiple sclerosis treatments is significant, especially in Europe and North America, where there is a high unmet clinical need for PPMS therapies [5][6] Group 3: Financial Position and Industry Context - As of June 30, 2025, Innovent holds approximately 7.68 billion yuan in cash and equivalents, indicating a strong financial position to support ongoing and future developments [6] - The global landscape for business development in the pharmaceutical industry is shifting, with increased collaboration opportunities between Chinese companies and foreign firms [5]
总金额超20亿美元,诺诚健华“斩获”海外BD大单
Huan Qiu Lao Hu Cai Jing· 2025-10-09 05:55
Core Insights - Nuo Cheng Jian Hua has signed a global licensing agreement with Zenas BioPharma worth over $2 billion, which includes an upfront payment of up to $100 million and milestone payments [1][2] - Zenas will gain global rights to Nuo Cheng Jian Hua's core product, Obexelimab, in the field of multiple sclerosis, along with rights to new oral IL-17AA/AF inhibitors and oral TYK2 inhibitors [2] - Obexelimab is a highly selective BTK inhibitor with strong CNS penetration, already commercialized since 2021 and included in the national medical insurance directory in 2022 [3] Financial Performance - Nuo Cheng Jian Hua reported a revenue of 731 million yuan in the first half of 2025, a year-on-year increase of 74.3%, with revenue from Obexelimab reaching 637 million yuan, up 52.8% [4] - The company narrowed its net loss to 30 million yuan in the first half of 2025, compared to a loss of 262 million yuan in the same period last year [4] - As of June 30, 2025, Nuo Cheng Jian Hua had cash and cash equivalents totaling 7.7 billion yuan [4]
首付1亿美元,潜在交易金额超20亿美元,A股创新药龙头宣布:授权给美国药企!股价大跌,但年内已翻倍
Mei Ri Jing Ji Xin Wen· 2025-10-09 04:24
Core Viewpoint - The company, Innovent Biologics, announced a licensing agreement with Zenas for its core product, Orelabrutinib, allowing Zenas to develop and commercialize it in multiple sclerosis and other non-oncology indications, while retaining oncology rights [1][4]. Group 1: Licensing Agreement Details - Innovent's subsidiary, InnoCare, will receive up to $100 million in upfront and milestone payments, along with 7 million shares of Zenas common stock, with potential total transaction value exceeding $2 billion [1][4]. - The agreement includes rights for two preclinical molecules, a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor, which are aligned with Zenas's focus on autoimmune diseases [1][5]. Group 2: Product and Market Potential - Orelabrutinib is currently approved for three indications in hematological cancers in China, with ongoing clinical trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [4][7]. - The global market for multiple sclerosis treatments is significant, particularly in Europe and North America, where there is a high unmet clinical need for effective therapies [7][8]. Group 3: Financial and Strategic Implications - The company has a strong cash position of approximately 7.68 billion yuan, which supports its ongoing research and development efforts [8]. - The licensing agreement reflects a shift in global business development strategies, emphasizing collaboration and shared success rather than merely selling products [7].
诺诚健华和Zenas就三款自免管线达成授权许可合作,潜在总交易金额超20亿美元
Cai Jing Wang· 2025-10-09 03:04
Core Insights - 诺诚健华 and Zenas BioPharma have entered into a licensing agreement for the global development and commercialization rights of 奥布替尼 in multiple sclerosis and other non-oncological indications [1][2] - Zenas will pay up to $100 million in upfront and milestone payments, with total transaction value exceeding $2 billion [1][2] - 奥布替尼 is a potential best-in-class oral BTK inhibitor with strong CNS penetration, currently undergoing clinical trials for multiple sclerosis [2][3] Group 1 - Zenas will receive exclusive global rights for 奥布替尼 in multiple sclerosis and non-oncological indications outside Greater China and Southeast Asia [2] - 诺诚健华 retains global rights for 奥布替尼 in oncology and in non-oncological indications within Greater China and Southeast Asia [2] - Zenas also gains rights to a novel oral IL-17 AA/AF inhibitor and a CNS-penetrant oral TYK2 inhibitor [1][2] Group 2 - A Phase III clinical trial has been initiated to evaluate the safety and efficacy of 奥布替尼 in primary progressive multiple sclerosis patients [2] - Zenas plans to start a second Phase III trial for secondary progressive multiple sclerosis in Q1 2026 [2] - In a previous Phase II trial, 奥布替尼 significantly reduced the number of new Gd+ T1 MRI brain lesions compared to placebo, demonstrating sustained reduction in inflammatory activity [3]
首付款1亿美元,潜在总交易金额超20亿美元 诺诚健华宣布年内第二笔BD授权,转让3款自免管线
Mei Ri Jing Ji Xin Wen· 2025-10-09 00:04
Core Viewpoint - The company announced a licensing agreement with Zenas for its core product, Orelabrutinib, in the field of multiple sclerosis and other non-oncological treatments, while retaining rights in oncology [1][2]. Group 1: Licensing Agreement Details - The agreement includes a $100 million upfront payment and potential milestone payments, with a total deal value exceeding $2 billion [1]. - Zenas will also issue 7 million shares of common stock to the company, with additional payments tied to clinical development and commercialization milestones [1]. - The agreement allows Zenas to develop and commercialize Orelabrutinib globally for multiple sclerosis and other non-cancer indications [1][2]. Group 2: Product and Market Insights - Orelabrutinib is currently approved for three indications in hematological cancers in China, with ongoing clinical trials for multiple sclerosis [2]. - The company retains exclusive global rights for Orelabrutinib in oncology, establishing a dual strategy of self-research in oncology and licensing in autoimmune diseases [2]. - The new oral IL-17 AA/AF inhibitor and the brain-penetrant oral TYK2 inhibitor are in preclinical stages, targeting autoimmune diseases like psoriasis and psoriatic arthritis [3]. Group 3: Market Context and Future Prospects - The global market for multiple sclerosis treatments is significant, particularly in Europe and North America, where the disease has a higher prevalence [5]. - The company’s Orelabrutinib shows advantages in kinase selectivity and binding affinity, indicating strong clinical development potential [5]. - The oral IL-17 AA/AF inhibitor addresses the challenge of injection-based therapies, which may improve patient compliance [5]. Group 4: Financial Position - As of June 30, 2025, the company holds approximately 7.68 billion yuan in cash and equivalents, indicating a strong financial position within the biotech sector [6].
诺诚健华与Zenas达成逾20亿美元授权协议
Bei Jing Shang Bao· 2025-10-08 11:34
Core Insights - InnoCare Pharma Inc., a wholly-owned subsidiary of the company, has signed a licensing agreement with Zenas BioPharma, granting Zenas global development and commercialization rights for Orelabrutinib in multiple sclerosis and other non-oncology therapeutic areas [1] - Zenas will pay up to $100 million in upfront and milestone payments, with total transaction value exceeding $2 billion, including stock issuance and royalties [1] Group 1 - The agreement includes rights to two preclinical molecules: a novel oral IL-17 AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor [1] - Zenas will issue 7 million shares of common stock to the company, with additional payments tied to clinical development, registration, and commercialization milestones [1] - The company is entitled to receive tiered royalties of up to the high teens percentage on annual net sales of the licensed products [1]
诺诚健华达成重磅对外授权合作 总交易额超20亿美金
Zheng Quan Shi Bao Wang· 2025-10-08 09:44
Core Insights - 诺诚健华 and Zenas BioPharma have entered into a significant licensing agreement, granting Zenas global development and commercialization rights for 奥布替尼 in multiple sclerosis and other non-oncology indications outside Greater China and Southeast Asia [1][2] - The total transaction value exceeds $2 billion, including an upfront payment of up to $100 million, milestone payments, and the issuance of 7 million shares of Zenas common stock [1][2] - 奥布替尼 is a potential best-in-class oral BTK inhibitor with strong CNS penetration, aimed at addressing challenges in the progression of multiple sclerosis [2][3] Company Developments - Zenas will initiate a Phase III clinical trial for 奥布替尼 in primary progressive multiple sclerosis (PPMS) in Q1 2026, following a successful Phase II trial that demonstrated significant efficacy [2][3] - The collaboration is seen as a crucial milestone for 诺诚健华 in its globalization efforts, with expectations of enhancing the clinical and commercial value of 奥布替尼 [3][4] - Zenas aims to advance two additional preclinical molecules, a novel oral IL-17AA/AF inhibitor and a brain-penetrant oral TYK2 inhibitor, into clinical development by 2026 [1][4] Market Potential - 奥布替尼 has shown promising clinical data, significantly reducing the number of new lesions in patients with relapsing-remitting multiple sclerosis (RRMS) [3][4] - The strategic partnership is expected to accelerate the clinical development of 奥布替尼 and maximize its market potential, particularly in the underserved areas of PPMS and secondary progressive multiple sclerosis (SPMS) [3][4] - Zenas is positioned to become a global, integrated biopharmaceutical company focused on the development and commercialization of treatments for autoimmune diseases, leveraging its collaboration with 诺诚健华 [3][4]
重磅!最高20亿美元!诺诚健华和Zenas就三款自免管线达成授权许可 包括开发治疗多发性硬化进入III期的BTK抑制剂奥布替尼
美股IPO· 2025-10-08 09:31
Core Insights - Orelabrutinib is a potential best-in-class oral small molecule BTK inhibitor with strong CNS penetration, currently in global Phase III clinical development for progressive forms of multiple sclerosis (MS) [1][2][3] - A Phase III trial for primary progressive MS (PPMS) has been initiated, while a trial for secondary progressive MS (SPMS) is expected to start in Q1 2026 [1][2][6] - Zenas BioPharma has entered a significant licensing agreement with InnoCare Pharma, acquiring global rights for Orelabrutinib in MS and other non-oncological indications outside Greater China and Southeast Asia [1][11] Clinical Development - The Phase III trial for PPMS is a global, multicenter, randomized, double-blind, placebo-controlled study assessing the safety and efficacy of Orelabrutinib at a daily dose of 80 mg [2][6] - The SPMS Phase III trial is also designed as a global, multicenter, randomized, double-blind, placebo-controlled study, expected to start in Q1 2026 [6][14] - Previous Phase II trials demonstrated significant reductions in Gd+ T1 MRI brain lesions at 12 and 24 weeks, with sustained effects up to 96 weeks [2][4] Strategic Collaboration - The collaboration between InnoCare and Zenas is seen as a milestone in global development, enhancing the clinical and commercial value of Orelabrutinib [3][4] - Zenas aims to leverage this partnership to advance its pipeline, including two additional preclinical molecules: a novel oral IL-17AA/AF inhibitor and a CNS-penetrant oral TYK2 inhibitor, both expected to enter clinical trials in 2026 [3][7][8] Financial Terms - Under the licensing agreement, Zenas will pay InnoCare up to $100 million in upfront and milestone payments, with total transaction value exceeding $2 billion [11] - Zenas will also issue 7 million shares of common stock to InnoCare, along with tiered royalties based on annual net sales of the licensed products [11] Company Profiles - InnoCare Pharma is a biopharmaceutical company focused on innovative drug development for oncology and autoimmune diseases, with a strong pipeline of products at various stages [16] - Zenas BioPharma is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for autoimmune diseases, with a focus on Orelabrutinib and Obexelimab [17][18]