Core Insights - The innovative drug sector is experiencing a significant bull market, with the entry threshold for top-performing stocks raised considerably [1] - In 2024, the median increase for the top 10 innovative drug companies was 57.9%, with the highest increase reaching 132.6%. In 2025, this trend intensified, with the median increase for the top 10 soaring to 495.41% and the highest increase hitting 1824% [2] Group 1: Top Performing Companies - Beihai Kangcheng-B achieved the highest increase in 2025, with a staggering 1824% rise, surprising many in the market [5] - Sanleaf Biotech-B followed with an impressive 870% increase, despite facing significant operational challenges, including a cash flow crisis and a major refund demand from GAVI [10][11] - Yaojie Ankang-B, despite being controversial, saw its stock price rise nearly ninefold in a short period, reaching a market cap close to 270 billion HKD [12][13] - Heptagon Pharmaceuticals-B ranked fourth with a 553% increase, driven by its dual-engine model of R&D and business development [14][15] - Xuan Bamboo Biotech-B, a newly listed company, achieved a 507% increase, benefiting from positive clinical trial results and inclusion in national insurance directories [17][18] - Deqi Pharmaceuticals-B saw a 483% increase, attributed to its innovative AI-driven T-cell connector platform [19][20] - Jike Si-B experienced a 401% increase, driven by its advancements in KRAS-targeted therapies [22][23] - Rongchang Biotech achieved a 400% increase, with its product Taite Xip demonstrating significant potential across multiple indications [24][25] - Paige Biotech saw a 342% increase, largely due to its GLP-1 pipeline's market momentum [27] - Baiaosaitu-B rounded out the top ten with a 315% increase, supported by strong revenue growth and positive market expectations for its upcoming H+A listing [28][30] Group 2: Market Dynamics - The surge in stock prices for many companies is not solely based on fundamental improvements but also reflects speculative trading behaviors [4] - The innovative drug sector's long-term health relies on the emergence of stocks driven by genuine innovation rather than short-term speculation [4] - The market's focus on liquidity and sentiment has led to significant price increases, but these may not be sustainable as market conditions change [31]

Core Viewpoint - The Hong Kong stock market has seen extreme gains in micro-cap stocks, with notable examples including Elephant Holdings Group, which surged by 6852.38%, highlighting a phenomenon of "survivorship bias" in the market [1]. Group 1: Stock Performance - Elephant Holdings Group (08635) experienced a price increase of 23.73% with a year-to-date gain of 6852.38% [1] - Base Champion Group (08460) saw a 4.63% rise, accumulating a year-to-date increase of 4164.15% [1] - Other significant gainers include Guangdong-Hong Kong Holdings (01396) with a 3305.59% increase, and Junyu Foundation (01757) with a 2665.77% rise [1] Group 2: Market Characteristics - The extreme percentage gains are attributed to a very low base price at the beginning of the year, allowing small amounts of capital to double stock prices, resulting in inflated percentage increases [2] - The price increases are primarily driven by trading factors such as speculative news, technical short squeezes, and concentrated shareholding rather than fundamental performance [2] - These stocks carry high risks due to low liquidity, making them susceptible to sharp declines after rapid increases, and the lack of transparency complicates investment decisions for ordinary investors [2]

Core Insights - The newly released "Commercial Health Insurance Innovative Drug Directory (2025)" marks the first of its kind in China, focusing on high-innovation drugs that exceed the basic medical insurance's scope [1][2] Group 1: Overview of the Commercial Health Insurance Innovative Drug Directory - The directory was developed by the National Healthcare Security Administration and includes high-priced innovative drugs, gene therapies, and specific rare disease treatments [1] - A total of 121 drug names were reviewed, with 19 drugs from 18 innovative pharmaceutical companies successfully included, resulting in an acceptance rate of approximately 15.7% [1] Group 2: Focus on Rare Diseases and Cancer Treatments - The directory includes drugs for Alzheimer's disease and rare diseases prevalent in children, such as Gaucher disease and neuroblastoma [2] - North Sea Kangcheng's Gaucher drug, the first domestically developed enzyme replacement therapy, was approved for use in patients aged 12 and older [2] Group 3: Impact on CAR-T Therapy - Five domestic CAR-T products were included in the directory, which is expected to significantly reduce patient out-of-pocket expenses and improve accessibility [3] - The inclusion of CAR-T products is seen as a milestone that will positively impact the entire industry chain, with companies planning to expand domestic supplier partnerships to enhance supply chain efficiency [3]

Core Viewpoint - The National Healthcare Security Administration and the Ministry of Human Resources and Social Security have issued the new National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, along with the first edition of the Commercial Health Insurance Innovative Drug Catalog, which will be implemented nationwide starting January 1, 2026 [1] Group 1 - The new dual catalog for medical insurance and commercial health insurance will officially take effect on January 1, 2026 [1] - Several listed companies, including Heng Rui Medicine, Fosun Pharma, Hai Si Ke, Bei Hai Kang Cheng, and Junshi Biosciences, have announced new drug inclusions, renewals, or new indications added to the updated national medical insurance catalog and the first edition of the commercial health insurance innovative drug catalog [1]

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]