Group 1 - The core point of the article is that Shijiazhuang Pharmaceutical Group (02005.HK) has received approval from the National Medical Products Administration of China for its active pharmaceutical ingredient, Ambroxol Hydrochloride, to be used in marketed formulations. Ambroxol Hydrochloride is an expectorant primarily used for treating respiratory diseases [1] - The company also announced that it has obtained production registration approvals for Calcium Gluconate and Sodium Chloride Injection (100ml:1g/0.8g) and Metronidazole Sodium Chloride Injection (100ml:0.5g/0.9g) [1]

Core Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].

Market Overview - The Hang Seng Index fell by 0.21%, down 49 points, closing at 23,857 points, while the Hang Seng Tech Index decreased by 0.59% [1] - The early trading volume in the Hong Kong stock market reached HKD 102.1 billion [1] Sector Performance - The non-ferrous metal sector showed strong performance, with institutions optimistic about sustained profitability; Luoyang Molybdenum Co. rose by 4% and Jiangxi Copper Co. increased by 3.11% [1] - The three major telecom operators in Hong Kong experienced gains, with China Unicom, China Mobile, and China Telecom all rising over 2% [1] Notable Stock Movements - China Silver Group surged over 23%, with spot silver prices reaching nearly USD 36, marking a 13-year high [1] - Longpan Technology saw a rise of 3.35% after signing a large order for 150,000 tons of lithium iron phosphate, indicating a boost in solid-state battery production [1] - Dongyue Group increased by 1.54% as prices for third-generation refrigerants continued to rise, positioning the company as a leader in R22 and R32 quotas [1] - Youjia Innovation rose by 7% after securing a key model for a new energy brand under Changan Automobile [1] - Shijiazhuang Pharmaceutical Group increased by 4.27% after obtaining production registration for calcium gluconate and sodium chloride injection [1] - Zhongxu Future surged over 11% as the issuance of domestic game licenses reached a new high, with multiple new titles planned for release within the year [1] Company-Specific Challenges - Dongfeng Group's stock fell over 3% amid clarification from its controlling shareholder that there are no current restructuring plans, with a reported 17.1% year-on-year decline in vehicle sales for the first five months [2] - Alibaba Health dropped by 3.46% as its profits for the fiscal year 2025 fell short of expectations, with UBS suggesting the company may struggle to maintain its current valuation [3] - The automotive sector faced renewed declines, with analysts predicting an unavoidable new round of price wars, leading to a trend of increased revenue without profit growth; XPeng Motors fell by 2.9% and Li Auto decreased by 1.46% [3]