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海通国际:维持康哲药业(00867)“优于大市”评级 目标价18.38港元
智通财经网· 2025-09-11 01:21
Core Viewpoint - Haitong International slightly adjusted the revenue forecast for Kangzheng Pharmaceutical (00867) for 2025-26E to 8.33/9.30 billion HKD, representing a year-on-year increase of 11.5%/11.6% [1] - The net profit forecast for the same period was adjusted to 1.67/1.88 billion HKD, reflecting a year-on-year growth of 3.4%/12.9% [1] - The valuation model was changed to a discounted cash flow (DCF) model to better reflect the long-term value of the pipeline cash flow from Demy Pharmaceutical, with a target price of 18.38 HKD (+85%) [1] Financial Performance - Kangzheng Pharmaceutical achieved a revenue of 4 billion HKD in the first half of the year, a year-on-year increase of 11% [2] - The revenue from major exclusive/brand products and innovative products was 2.9 billion HKD, up 21% year-on-year, which is the core driver of the company's performance recovery [2] - The gross profit margin was 72%, with R&D expenses of 570 million HKD (down 8% year-on-year) and a net profit of 940 million HKD (up 3% year-on-year) [2] Business Growth Drivers - The recovery in revenue is attributed to the clearance of the impact from existing centralized procurement products and the steady growth of core products such as Weifurui and Meitai Tong [3] - Exclusive/brand and innovative product sales accounted for 62.1% of total revenue, up from 56.1% in the same period last year [3] - Revenue by segment includes 2.2 billion HKD from cardiovascular, 1.4 billion HKD from digestive/immunity, 500 million HKD from skin health (up 104%), and 360 million HKD from ophthalmology [3] Innovation and Pipeline - The company has three NDA applications under review and approximately ten clinical trials progressing in China, including treatments for ischemic stroke and atopic dermatitis [4] - Potential products in development include Povorcitinib and CMS-D001, targeting various conditions [4] Spin-off Plans - Kangzheng Pharmaceutical plans to spin off Demy Pharmaceutical for independent listing on the Hong Kong Stock Exchange by April 2025 [5] - Demy Pharmaceutical's pipeline addresses significant unmet clinical needs in skin diseases and has over 650 sales professionals covering more than 10,000 hospitals [5]
康哲药业(00867.HK):就治疗轻度至中度阿尔茨海默型痴呆症状的改良型新药ZUNVEYL中国上市许可申请已获受理
Ge Long Hui· 2025-07-28 09:41
Core Viewpoint - 康哲药业's new drug ZUNVEYL has received acceptance for its New Drug Application (NDA) from the National Medical Products Administration (NMPA) in China, aimed at treating mild to moderate Alzheimer's disease symptoms [1] Group 1: Product Details - ZUNVEYL is a new generation acetylcholinesterase inhibitor (AChEI) that improves cognitive and memory functions in Alzheimer's patients by increasing central acetylcholine levels [2] - The drug is a prodrug of galantamine, designed to reduce gastrointestinal side effects and improve patient tolerance, with recorded gastrointestinal adverse events below 2% [2] - ZUNVEYL is the second oral therapy for Alzheimer's approved by the FDA in the last decade, potentially enhancing medication adherence among patients [2] Group 2: Market Context - Alzheimer's disease is a chronic neurodegenerative condition, with Alzheimer's-type dementia accounting for 50% to 70% of all dementia cases, affecting approximately 9.83 million patients in China [3] - The increasing aging population is expected to raise the number of Alzheimer's patients, intensifying the disease burden [3] - Current Alzheimer's medications primarily focus on improving cognitive symptoms, with a significant demand for safer treatment options due to high side effect rates of existing drugs [3] Group 3: Strategic Partnerships - 康哲药业 has signed a licensing and collaboration agreement with Alpha Cognition Inc. for ZUNVEYL, granting exclusive rights for development and commercialization in Asia (excluding Japan and the Middle East), Australia, and New Zealand [4] - The agreement is set for an initial term of twenty years, with automatic five-year extensions unless terminated by either party [4] - ZUNVEYL is expected to diversify 康哲药业's innovative drug portfolio and enhance its competitive strength in the market, potentially benefiting the company's performance upon approval [4]
康哲药业(00867) - 自愿性及业务进展公告 就治疗轻度至中度阿尔茨海默型痴呆症状的改良型新药Z...
2025-07-28 09:31
自願性及業務進展公告 就治療輕度至中度阿爾茨海默型癡呆症狀的 改良型新藥ZUNVEYL中國上市許可申請已獲受理 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,改良型新藥ZUNVEYL(擬定通用名:葡萄糖酸苯加蘭他敏腸溶片) (「ZUNVEYL」或「產品」)新藥上市許可申請(NDA)已於二零二五年七月二十八 日獲得中國國家藥品監督管理局(NMPA)受理。產品擬用於治療成人輕度至中度阿爾 茨海默型癡呆症狀。 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。 本公告乃由本公司自願刊發,旨在向潛在投資者及本公司股東通知本集團最新業務進 展,建議股東和投資者在進行本公司股票及其他證券的交易時謹慎操作。 ZUNVEYL於二零二四年七月獲得美國食品和藥物管理局(FDA)批准上市用於治療成 人輕度至中度阿爾茨海默型癡呆症狀,屬於新一代乙酰膽鹼酯酶抑制劑(AChEI),通 過抑制乙酰膽鹼酯酶 ...