Core Insights - The company Beihai Kangcheng-B (01228) announced that its domestically developed enzyme replacement therapy CAN103 has been included in China's first version of the "Commercial Insurance Innovative Drug Directory," which will be implemented starting January 1, 2026 [1] Group 1: Product Development - CAN103 was approved for market launch on May 13, 2025, making it the first domestically developed enzyme replacement therapy for adolescents aged 12 and older, as well as adults with Type I and Type III Gaucher disease in China [1] - On July 2, 2025, CAN103 was officially prescribed at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, marking its entry into clinical application [1] Group 2: Market Impact - The inclusion of CAN103 in the insurance directory is considered a milestone achievement for the company, as it ensures that Gaucher disease patients will have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [1]

Core Viewpoint - The company has successfully included its innovative enzyme replacement therapy, CAN 103, in China's first version of the "Commercial Insurance Innovative Drug Directory," effective from January 1, 2026, marking a significant milestone for the group [1] Group 1: Product Development - CAN 103 is the first domestically developed enzyme replacement therapy in China, approved for use in adolescents aged 12 and above and adults with Type I and III Gaucher disease [1] - The drug was approved for market launch on May 13, 2025, and is recognized as the first innovative biological drug in China to pass the segmented production inspection for biological products [1] Group 2: Clinical Application - On July 2, 2025, CAN 103 was prescribed for the first time at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, indicating its official entry into clinical use [1] - The introduction of CAN 103 is expected to significantly enhance the accessibility of medication for domestic patients [1] Group 3: Market Impact - The inclusion of CAN 103 in the insurance directory ensures that Gaucher disease patients will have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [1]

Core Viewpoint - The inclusion of CAN 103 in China's first version of the "Commercial Insurance Innovative Drug Directory" marks a significant milestone for the company, ensuring broader access to effective domestic enzyme replacement therapy for Gaucher disease patients [1][2]. Group 1: Product Development and Approval - CAN 103 is the first domestically developed enzyme replacement therapy for Gaucher disease in China, approved for use in adolescents aged 12 and above and adults with Type I and III Gaucher disease [1]. - The drug was approved for market launch on May 13, 2025, and officially entered clinical application on July 2, 2025, at Xinhua Hospital affiliated with Shanghai Jiao Tong University School of Medicine [1]. Group 2: Regulatory and Market Context - The "Commercial Insurance Innovative Drug Directory" is set to be implemented on January 1, 2026, and includes innovative drugs that exceed basic insurance coverage and have significant clinical value [1]. - In the 2025 medical insurance negotiations, 121 drug varieties applied for inclusion in the directory, but only 24 were selected for negotiation [1]. Group 3: Impact on Patients and Healthcare - The inclusion of CAN 103 in the directory will ensure that Gaucher disease patients have access to safe and effective domestic enzyme replacement therapy, providing broader and more comprehensive treatment coverage [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，概不就因本公告全部或任何部分內容而產生或因依賴該等內 容而引致的任何損失承擔任何責任。 CAN 103於2025年5月13日獲批上市，是中國首個本土自主研發生產適用於12歲及以上青少年和成人 I型和Ⅲ型戈謝病患者的長期酶替代療法，亦為中國首個通過生物製品分段生產檢查的創新生物藥。 於2025年7月2日，CAN 103在上海交通大學醫學院附屬新華醫院開出首方，標誌著該藥物正式進入 臨床應用，未來將大大提升國內患者用藥可及。 CANbridge Pharmaceuticals Inc. 北海康成製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1228） 本公司認為，CAN 103納入該目錄為本集團的里程碑成就，乃由於此舉將確保戈謝病患者用得上、 用得起安全有效的國產酶替代療法，獲得更廣泛更全面的治療保障。 自願公告 北海康成製藥有限公司（「本公司」，連同其附屬公司，統稱「本集團」）董事會欣然宣佈，本集團的國 內首個本土自主研發生產的酶替代療法一類創新藥CAN 103已成功納入中國第 ...

Core Insights - Beihai Kangcheng Pharmaceutical Co., Ltd. has successfully included its innovative drug, Goreni, in China's first "Commercial Insurance Innovative Drug Directory," effective from January 1, 2026 [1][3] - Goreni is the first domestically developed enzyme replacement therapy for patients aged 12 and above with Type I and III Gaucher disease, marking a significant advancement in the treatment of rare diseases in China [3][4] Company Overview - Beihai Kangcheng is a leading global biopharmaceutical company focused on rare diseases, dedicated to the research, development, and commercialization of innovative therapies [1] - The company has formed a strategic partnership with Baiyang Pharmaceutical, which invested in Beihai Kangcheng in August 2025, focusing on the commercialization of rare disease products [1][4] Market Context - In the 2025 National Medical Insurance negotiations, 121 products applied for the Commercial Insurance Innovative Drug Directory, with only 19 drugs from 18 innovative companies successfully included, highlighting the competitive landscape for innovative drugs in China [1] - The Commercial Insurance Innovative Drug Directory targets high-innovation drugs not yet included in the basic medical insurance catalog, providing broader access to effective domestic treatments for patients [4] Future Outlook - The inclusion of Goreni in the directory is expected to enhance the accessibility of this innovative therapy for Gaucher disease patients in China, reflecting the urgent medical needs in the enzyme replacement therapy sector [3][4] - Baiyang Pharmaceutical is actively expanding its portfolio in the innovative drug sector, with investments in various therapeutic areas, indicating a robust strategy for growth and innovation in the pharmaceutical industry [4]

Core Insights - Beihai Kangcheng Pharmaceutical Co., Ltd. has successfully included its innovative drug, Geronine®, in China's first "Commercial Insurance Innovative Drug Directory," effective from January 1, 2026 [1][3] - Geronine® is the first domestically developed enzyme replacement therapy for patients aged 12 and above with Type I and III Gaucher disease, marking a significant advancement in the treatment of rare diseases in China [3][4] Company Overview - Beihai Kangcheng is a leading global biopharmaceutical company focused on rare diseases, dedicated to the research, development, and commercialization of innovative therapies [1] - The company has established a strategic partnership with Baiyang Pharmaceutical, which invested in Beihai Kangcheng in August 2025, focusing on the commercialization of rare disease products [1][4] Market Context - In the 2025 National Medical Insurance negotiations, 121 products applied for the Commercial Insurance Innovative Drug Directory, with only 19 drugs from 18 innovative companies successfully included, highlighting the competitive landscape for innovative drugs in China [1] - The Commercial Insurance Innovative Drug Directory aims to support high-innovation drugs that are not yet included in the basic medical insurance catalog, providing broader access to effective treatments for patients [4] Future Prospects - The inclusion of Geronine® in the directory is expected to enhance the accessibility of this innovative domestic enzyme replacement therapy for Gaucher disease patients, reflecting the urgent medical needs in this area [3][4] - Baiyang Pharmaceutical is actively expanding its portfolio in the innovative drug sector, with investments in various therapeutic areas, indicating a commitment to advancing healthcare solutions in China [4]

Core Viewpoint - The Hong Kong stock market saw a rise in several innovative drug concept stocks during the morning session, indicating positive investor sentiment in the biotech sector [1] Group 1: Stock Performance - WuXi AppTec (02126.HK) increased by 8.77%, reaching HKD 3.35 [1] - Kintor Pharmaceutical (02171.HK) rose by 3.8%, trading at HKD 18.87 [1] - Beihai Kangcheng (01228.HK) saw a gain of 3.38%, priced at HKD 2.45 [1] - Junshi Biosciences (01877.HK) climbed by 2.29%, with a share price of HKD 24.1 [1]

Core Viewpoint - The article highlights a significant rise in the stock prices of several innovative pharmaceutical companies following the announcement of the 2025 National Medical Insurance drug list, which includes a substantial number of new innovative drugs [1] Group 1: Stock Performance - WuXi AppTec (02126) saw an increase of 8.77%, trading at HKD 3.35 [1] - Kintor Pharmaceutical (02171) rose by 3.8%, reaching HKD 18.87 [1] - Beihai Kangcheng (01228) increased by 3.38%, priced at HKD 2.45 [1] - Junshi Biosciences (01877) gained 2.29%, with a share price of HKD 24.1 [1] Group 2: Drug List Adjustments - The 2025 National Medical Insurance drug list is the 8th adjustment since the establishment of the National Healthcare Security Administration [1] - A total of 114 new drugs were added to the list, including 50 Class 1 innovative drugs [1] Group 3: Notable Drug Inclusions - Fosun Pharma's (600196) Luwomei Tablets and Beihai Kangcheng's injectable Vilazodone Beta were included in the commercial insurance innovative drug list [1] - The highly anticipated CAR-T cell therapies from various companies, including Fosun Kairui's Acalabrutinib Injection and WuXi AppTec's Regorafenib Injection, were also included in the first batch of commercial insurance innovative drug list [1]

智通财经APP获悉，部分创新药概念股早盘走高，截至发稿，药明巨诺-B(02126)涨8.77%，报3.35港 元；科济药业-B(02171)涨3.8%，报18.87港元；北海康成-B(01228)涨3.38%，报2.45港元；君实生物 (01877)涨2.29%，报24.1港元。 值得注意的是，备受瞩目的百万CAR-T细胞疗法——复星凯瑞的阿基仑赛注射液、药明巨诺的瑞基奥仑 赛注射液、合源生物的纳基奥仑赛注射液、驯鹿生物的伊基奥仑赛注射液、恺兴生命科技的泽沃基奥仑 赛注射液均被纳入首批商保创新药目录。 消息面上，2025年国家基本医疗保险、生育保险和工伤保险药品目录是国家医保局成立以来的第8次调 整。本次目录调整新增114种药品，其中50种为1类创新药。据智通财经报道，复星医药的芦沃美替尼片 进入2025年医保目录，北海康成的注射用维拉苷酶β进入商保创新药目录。 ...

Group 1 - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have issued a new drug catalog for basic medical insurance, maternity insurance, and work injury insurance, which will take effect on January 1, 2026. This marks the 8th adjustment of the medical insurance drug catalog since the establishment of the National Healthcare Security Administration [1] - The recent adjustment adds 114 new drugs, including 50 first-class innovative drugs. Notably, several rare disease medications have been included in the 2025 medical insurance catalog and the commercial health insurance innovative drug catalog [1] - Specific drugs such as Fosun Pharma's Luvofemin and Beihai Kangcheng's Vilazodone have been included in the 2025 medical insurance catalog and the commercial health insurance innovative drug catalog, respectively. Additionally, five CAR-T therapies have been added to the commercial health insurance innovative drug catalog [1] Group 2 - John Yang, the Asia-Pacific healthcare research director at Citibank, stated that biotechnology, particularly innovative drugs, will be a top priority for China in the coming years. He emphasized the need for China to upgrade production lines and capabilities, as well as expand clinical management capabilities to develop the entire ecosystem [1] - Morgan Stanley's healthcare research head in China, Yang Huang, echoed similar sentiments, noting that biomanufacturing has been identified by the government as a key economic growth driver during the 14th Five-Year Plan period [1] Group 3 - The head of the National Healthcare Security Administration, Zhang Ke, indicated plans to accelerate the construction of a healthcare imaging cloud based on medical insurance data, aiming for nationwide interoperability and recognition of medical insurance imaging by 2027 [4]