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康哲药业与智翔金泰就唯康度塔单抗注射液及斯乐韦米单抗注射液签订合作协议
Zhi Tong Cai Jing· 2025-09-22 12:10
Core Viewpoint - The company has signed exclusive collaboration agreements for two monoclonal antibody products, GR2001 and GR1801, which target passive immunity for tetanus and rabies, respectively, with a focus on commercialization in mainland China and the Asia-Pacific region, as well as the Middle East and North Africa [1][2]. Group 1: Product Details - GR2001 is a recombinant humanized monoclonal antibody targeting the C-terminal of Tetanus Neurotoxin (TeNT), providing passive immunity by blocking TeNT from entering neuronal cells [2]. - GR1801 is a recombinant fully human bispecific antibody targeting the glycoprotein of the rabies virus, preventing the virus from infecting neurons before the active immunity from rabies vaccination takes effect [2]. Group 2: Market Potential and Strategic Positioning - The passive immunity market for tetanus and rabies is significant, with existing products having limitations in safety and accessibility [3]. - GR2001 offers better safety and efficacy compared to human tetanus immunoglobulin (HTIG), providing rapid and long-lasting protection for patients [3]. - GR1801 is the first globally to target specific epitopes of the rabies virus glycoprotein, aligning with WHO development recommendations, and is designed for large-scale standardized production [3]. - If approved, both products are expected to provide new treatment options for patients in China and positively impact the company's performance through synergy with existing products [3].
智翔金泰签订唯康度塔单抗和斯乐韦米单抗注射液商业化合作,将获得首付款、里程碑付款约5.1亿元
Bei Jing Shang Bao· 2025-09-22 11:58
Core Insights - Zhixiang Jintai (688443) announced a collaboration agreement with Tibet Kangzhe Pharmaceutical Development Co., Ltd. and RXILIENT MEDICAL PTE. LTD. for the exclusive rights to two monoclonal antibody injections [1] Group 1: Collaboration Details - The agreement includes an upfront payment and milestone payments totaling approximately 510 million yuan [1] - Zhixiang Jintai will provide commercialization and promotional services for the products [1] - Tibet Kangzhe will hold exclusive commercialization rights for the two products in mainland China [1] - RXILIENT will obtain exclusive licensing rights for the products in the Asia-Pacific region, as well as the Middle East and North Africa [1]
康哲药业:与智翔金泰签订合作协议
Xin Lang Cai Jing· 2025-09-22 11:56
康哲药业公告,公司附属公司与中国生物制药企业智翔金泰签订合作协议,获得了唯康度塔单抗注射液 和斯乐韦米单抗注射液在中国大陆的独家商业化权,以及亚太地区和中东、北非的独家许可权。唯康度 塔单抗注射液用于破伤风治疗,斯乐韦米单抗注射液用于狂犬病治疗。 ...
康哲药业(00867) - 自愿性及业务进展公告 就1类创新型治疗用生物製品重组人源化抗破伤风毒素单...
2025-09-22 11:50
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,並表明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。 自願性及業務進展公告 就1類創新型治療用生物製品 重組人源化抗破傷風毒素單克隆抗體唯康度塔單抗注射液 及重組全人源抗狂犬病病毒雙特異性抗體斯樂韋米單抗注射液 簽訂合作協議 China Medical System Holdings Limited(「本公司」,連同其附屬公司統稱為「本 集團」)欣然宣佈,於二零二五年九月二十二日,本集團通過本公司附屬公司與重慶智 翔金泰生物製藥股份有限公司(「智翔金泰」)就用於破傷風的被動免疫適應症的1類 治療用生物製品唯康度塔單抗(GR2001)注射液(「唯康度塔單抗注射液」)及用於疑 似狂犬病病毒暴露後的被動免疫適應症的1類治療用生物製品斯樂韋米單抗(GR1801) 注射液(「斯樂韋米單抗注射液」)分別簽訂獨家合作協議(「協議」)。 根據協議,本集團獲得了唯康度塔單抗注射液及斯樂韋米單抗注射液在中國大陸的獨家 商業化權與除中國大陸之外的亞太地區及中東、北非的獨家許可權。合作 ...
智翔金泰签订唯康度塔单抗注射液以及斯乐韦米单抗注射液商业化合作协议
Zhi Tong Cai Jing· 2025-09-22 11:45
Core Viewpoint - The company, Zhixiang Jintai, has entered into exclusive cooperation agreements with subsidiaries of Kangzhe Pharmaceutical Holdings and RXILIENT Medical for two monoclonal antibody injections, GR2001 and GR1801, which will provide significant financial benefits and exclusive commercialization rights in various regions [1][2]. Group 1: GR2001 Injection Agreement - Zhixiang Jintai will receive upfront payments and milestone payments totaling up to approximately 260 million RMB for the GR2001 injection [1] - Kangzhe Pharmaceutical will obtain exclusive commercialization rights for GR2001 in mainland China, while RXILIENT will have exclusive licensing rights for the Asia-Pacific region and the Middle East and North Africa [1] - The company will also earn revenue based on net sales adjustments from regions outside mainland China and will pay promotional service fees to Kangzhe Pharmaceutical based on sales revenue in mainland China [1] Group 2: GR1801 Injection Agreement - Zhixiang Jintai will receive upfront payments and milestone payments totaling up to approximately 250 million RMB for the GR1801 injection [2] - Kangzhe Pharmaceutical will gain exclusive commercialization rights for GR1801 in mainland China, while RXILIENT will have exclusive licensing rights for the Asia-Pacific region and the Middle East and North Africa [2] - Similar to the GR2001 agreement, the company will earn revenue based on net sales adjustments from regions outside mainland China and will pay promotional service fees to Kangzhe Pharmaceutical based on sales revenue in mainland China [2]
智翔金泰:签订合作协议 将获得首付款、里程碑付款约5.1亿元人民币等权益
Core Viewpoint - Zhixiang Jintai (688443.SH) has signed exclusive cooperation agreements with Tibet Kangzhe and RXILIENT for the commercialization of GR2001 and GR1801 monoclonal antibody injections, which is expected to positively impact the company's performance and long-term development [1] Group 1: Partnership Details - Tibet Kangzhe will obtain exclusive commercialization rights for the two products in mainland China [1] - RXILIENT will receive exclusive licensing rights for the Asia-Pacific region, as well as the Middle East and North Africa, excluding mainland China [1] Group 2: Financial Implications - Zhixiang Jintai will receive an upfront payment and milestone payments totaling approximately 510 million RMB [1] Group 3: Future Outlook - The cooperation is anticipated to have a positive effect on the company's performance and long-term growth [1] - There are uncertainties related to the drug registration process and commercialization risks [1]
智翔金泰:西藏康哲和RXILIENT就唯康度塔单抗注射液(GR2001注射液)以及斯乐韦米单抗注射液(GR1801注射液)分别签订独家合作协议
Ge Long Hui· 2025-09-22 11:25
Core Viewpoint - The company, Zhixiang Jintai, has signed exclusive cooperation agreements with Kangzhe Pharmaceutical and RXILIENT for the commercialization of two monoclonal antibody injections, GR2001 and GR1801, which will provide significant financial benefits and market access in various regions [1][2][3] Group 1: Agreements and Financial Terms - The agreements grant exclusive commercialization rights for GR2001 to Tibet Kangzhe in mainland China, while RXILIENT receives exclusive licensing rights for the Asia-Pacific region and the Middle East and North Africa [1] - Zhixiang Jintai will receive upfront and milestone payments totaling up to approximately 260 million RMB for GR2001, along with revenue from sales in mainland China and supply income based on net sales in other regions [1] - For GR1801, Tibet Kangzhe will also obtain exclusive commercialization rights in mainland China, with RXILIENT securing similar rights in the Asia-Pacific region and the Middle East and North Africa, and Zhixiang Jintai will receive payments up to approximately 250 million RMB [2] Group 2: Product Details - GR2001 is a recombinant humanized monoclonal antibody targeting the C-terminal of the Tetanus Neurotoxin (TeNT), classified as a Class 1 therapeutic biological product, providing passive immunity by blocking TeNT from entering neuronal cells [2] - GR1801 is a recombinant fully human bispecific antibody targeting the glycoprotein of the Rabies Virus (RABV), also classified as a Class 1 therapeutic biological product, designed to prevent rabies by blocking the virus's interaction with receptors before the vaccine can take effect [3]
智翔金泰:签订合作协议 获首付款2.6亿元及最高2.5亿元里程碑付款
Xin Lang Cai Jing· 2025-09-22 11:14
Core Viewpoint - The company has entered into exclusive collaboration agreements for two monoclonal antibody injections, GR2001 and GR1801, with subsidiaries of Kangzhe Pharmaceutical and RXILIENT MEDICAL, indicating a strategic move to enhance its product portfolio and market presence in specific regions [1] Group 1 - The company will receive upfront payments and milestone payments as part of the collaboration agreements [1] - Kangzhe Pharmaceutical will obtain exclusive commercialization rights for the two products in mainland China [1] - RXILIENT MEDICAL will gain exclusive licensing rights for the products in the Asia-Pacific region, as well as the Middle East and North Africa [1]
兴证国际:维持康哲药业(00867)“买入”评级 独家产品及创新产品成为增长新驱动
智通财经网· 2025-09-16 01:28
Core Viewpoint - The report from Xingzheng International adjusts the profit forecast for Kangzhe Pharmaceutical (00867), expecting net profit for 2025-2027 to be CNY 1.661 billion, CNY 1.917 billion, and CNY 2.272 billion, representing year-on-year growth of 2.54%, 15.39%, and 18.57% respectively, maintaining a "Buy" rating [1] Group 1: Financial Performance - In the first half of 2025, the company's revenue reached CNY 4.002 billion, a year-on-year increase of 10.8%, with pharmaceutical sales contributing CNY 4.670 billion, up 8.9% [2] - The net profit attributable to shareholders was CNY 941 million, reflecting a 3.4% year-on-year growth, with a gross margin of 61.7% and a sales expense ratio of 30.3%, down 2.1 percentage points [2] - The company declared an interim dividend of CNY 0.1555 per share, totaling CNY 376 million, which accounts for approximately 39.99% of the net profit for the first half of 2025 [2] Group 2: Growth Drivers - The negative impact of national procurement on operating performance has diminished, with major exclusive, branded, and innovative products continuing to drive sales growth, accounting for 62.1% of total revenue, an increase of 6.0 percentage points year-on-year [3] - Revenue from the cardiovascular disease segment was CNY 2.216 billion, up 0.6%, while the digestive and autoimmune disease segment generated CNY 1.411 billion, a 4.9% increase; the skin health segment (Demei Pharmaceutical) saw revenue of CNY 498 million, up 104.3% [3] Group 3: Innovation and Product Development - The company has accelerated its innovation strategy since 2025, with five approved innovative drugs (Yiluqu, Weifurui, Meitai Tong, Weituo Ke, Laifulan) set to release commercial value [4] - Three innovative drugs are under NDA review in China, and two self-developed products have received IND approval, alongside two newly developed collaborative innovative products [4] - A new injectable product (Lizhenran) was approved in China in July 2025 [4] Group 4: Strategic Initiatives - The company plans to spin off its skin health business, Demei Pharmaceutical, for independent listing on the Hong Kong Stock Exchange, which has three marketed products and four in clinical stages, covering major skin disease treatments [5] - Additionally, two skincare products aimed at disease prevention and care have been launched [5]
兴证国际:维持康哲药业“买入”评级 独家产品及创新产品成为增长新驱动
Zhi Tong Cai Jing· 2025-09-16 01:27
Core Viewpoint - The report from Xingzheng International adjusts the profit forecast for Kangzhe Pharmaceutical (00867), expecting net profit attributable to shareholders to reach 1.661 billion yuan, 1.917 billion yuan, and 2.272 billion yuan for 2025-2027, with corresponding growth rates of 2.54%, 15.39%, and 18.57% respectively, maintaining a "buy" rating [1] Group 1 - In the first half of 2025, the company's revenue was 4.002 billion yuan, a year-on-year increase of 10.8%, with a profit attributable to shareholders of 941 million yuan, up 3.4% [2] - The gross margin for drug sales was 61.7%, with a sales expense ratio of 30.3%, down 2.1 percentage points, and a management expense ratio of 9.2%, up 0.8 percentage points [2] - The company declared an interim dividend of 0.1555 yuan per share, totaling 376 million yuan, which accounts for approximately 39.99% of the net profit attributable to shareholders for the first half of 2025 [2] Group 2 - The negative impact of national procurement on operating performance has passed, with major exclusive and innovative products driving sales growth, accounting for 62.1% of total revenue, an increase of 6.0 percentage points year-on-year [3] - Revenue from cardiovascular-related products was 2.216 billion yuan, up 0.6%; revenue from digestive/immunology-related products was 1.411 billion yuan, up 4.9%; revenue from skin health products was 498 million yuan, up 104.3%; and revenue from ophthalmology products was 358 million yuan, up 17.7% [3] Group 3 - The company has accelerated its innovation efforts in 2025, with five approved innovative drugs expected to release commercial value, and three innovative drugs currently under NDA review in China [4] - Two self-developed products have received IND approval, and two new collaborative innovative products have been added [4] - A new injectable product has been approved in China as of July 2025 [4] Group 4 - The company plans to spin off its skin health business, Dermy Pharmaceutical, for independent listing on the Hong Kong Stock Exchange, which has three marketed products and four in clinical stages as of the first half of 2025 [5] - Dermy Pharmaceutical has also launched two skincare product lines aimed at preventing and treating skin diseases [5]