Core Viewpoint - The recent surge in drug notification letters from the National Medical Products Administration (NMPA) indicates a tightening of approval processes for generic drugs in China, with a significant increase in rejected or withdrawn applications in December 2023 compared to previous months [3][9]. Summary by Sections Drug Application Status - In December 2023, 167 drug notification letters were issued, with 102 related to generic drug applications, marking a doubling of rejections or withdrawals compared to November [3][4]. - The rejected or withdrawn applications include a variety of therapeutic areas such as cardiovascular, metabolic diseases, and oncology, with notable drugs like Sacubitril/Valsartan and Levofloxacin involved [6][8]. Industry Response - Some companies, like Jiutian Pharmaceutical, have publicly stated reasons for their withdrawal, citing the need for further data improvement after discussions with the NMPA [7]. - Issues primarily stem from raw material quality rather than the formulations themselves, as reported by some rejected applicants [7]. Regulatory Environment - The approval process for chemical generic drugs is tightening, as indicated by new drafts released by the NMPA that outline stricter criteria for approval, including the rejection of applications based on existing documentation without the need for additional submissions [9][10]. - The new guidelines aim to clarify significant deficiencies in bioequivalence studies, which have been a common reason for application failures [10]. Market Dynamics - China remains a major player in the generic drug market, but increasing competition and the inclusion of more innovative drugs in the medical insurance catalog are pressuring profit margins for generics [12][13]. - The market for chemical generics is projected to maintain a 50% share of the overall pharmaceutical market in 2024, with a notable increase in the number of approved generic varieties [13]. Competition and Industry Trends - The number of generic drug varieties has surged, leading to intensified competition and market saturation, with a significant rise in the number of products with five or more manufacturers [13]. - Concerns about low-level duplication in the generic drug sector have prompted calls for regulatory reforms to enhance the quality and efficiency of the approval process [15].

Core Viewpoint - The recent surge in drug notification letters from the National Medical Products Administration indicates a tightening of approval processes for generic drugs in China, with a significant increase in rejected or withdrawn applications in December compared to November [1][5]. Group 1: Drug Approval Trends - As of December 19, 2023, a total of 167 drug notification letters were issued, with 102 related to generic drug applications, marking a doubling in rejections or withdrawals compared to November [1]. - The therapeutic areas affected include cardiovascular, metabolic diseases, nervous system, respiratory, anti-infection, oncology, ophthalmology, dermatology, and digestive systems, with specific drugs like sacubitril/valsartan and sitagliptin/metformin among those impacted [1]. - Multiple manufacturers faced challenges with the same drug, such as the allergy treatment bilastine, which had six companies involved in unsuccessful applications [2]. Group 2: Reasons for Rejections - Some companies, like Jiutian Pharmaceutical, have publicly stated that their withdrawal was due to the need for further data refinement after discussions with the National Drug Review Center [3]. - Manufacturers of rejected generic drugs indicated that the primary issues were related to raw materials rather than the formulations themselves [3]. Group 3: Regulatory Changes - The approval process for generic drugs is tightening, as indicated by the recent drafts of guidelines from the National Medical Products Administration, which outline significant deficiencies in pharmaceutical research and bioequivalence studies [5][6]. - The new guidelines suggest that applications with major deficiencies will not be allowed to supplement their materials, leading to more rejections based on existing documentation [5]. Group 4: Market Dynamics - The Chinese generic drug market is facing increased competition, with a significant number of companies vying for approval of similar products, leading to market saturation [7]. - The report from the Chinese Academy of Medical Sciences indicates that by 2024, generic drugs will still account for 50% of the overall pharmaceutical market, with a notable increase in the number of approved generic varieties [7]. - The market concentration remains low, with the top ten companies holding around 22% of the market share, indicating ongoing challenges for profitability in the generic sector [7]. Group 5: Industry Insights - Industry experts have noted that the increasing number of generic drug projects, often with lower development costs compared to innovative drugs, contributes to market saturation and competition [8]. - Concerns about "internal competition" in the generic drug sector have prompted calls for regulatory adjustments to optimize the approval process and reduce unnecessary resource expenditure [8].

Major Events - Meet Xiaomian (02408) has set its share price at HKD 7.04, with the Hong Kong public offering receiving a subscription rate of 425.97 times [1] - Naxin Micro (02676) has set its share price at HKD 116.00 per H-share, with an expected listing date of December 8 [1] - Tianyu Semiconductor (02658) received a subscription rate of 60.63 times for its Hong Kong public offering, with a listing date of December 5 [1] - China Petroleum & Chemical Corporation (00857) plans to acquire all equity interests in the Xiangguosi Gas Storage and Liaohe Gas Storage [1] - China Power (00931) intends to issue discounted shares to the International Finance Corporation to expand its capital base and is advancing a large LNG project acquisition [1] - TECHSTARACQ-Z (07855) has finalized financing of approximately HKD 371 million from Seyond Holdings Ltd., with NIO Inc. (09866) increasing its subscription by HKD 286.7 million [1] - Kelun-Biotech (06990) has established a strategic partnership with Crescent Biopharma to jointly develop and commercialize cancer treatment methods [1] - Yihe Holdings (01662) subsidiary Trio AI has formed a strategic partnership with ABBY Pay to explore and implement AI-driven payment processing solutions [1] - Quzhi Group (00917) has established a strategic partnership with Dubai to jointly promote the HOLOX project [1] - Sihuan Pharmaceutical (02005) has received approval from the National Medical Products Administration for Bilastine and Picotamide to be used as raw materials in listed formulations [1] - China Biopharmaceutical (01177) has received clinical trial application approvals for TQF3250, an oral GLP-1 receptor agonist, from NMPA and FDA [1] - Country Garden (02007) has received approval from relevant bondholders for its domestic bond restructuring plan [1] - Longguang Group (03380) has accumulated debt restructuring offers for bonds with a total face value of RMB 13.66 billion [1] - United Energy Group (00467) has completed a financing loan arrangement for reserves [1] Buybacks/Reductions - Tencent Holdings (00700) repurchased 1.044 million shares at a cost of approximately HKD 636 million on December 4 [2] - Midea Group (00300) repurchased 1.2177 million A-shares for a total of approximately RMB 99.9982 million on December 4 [2] - COSCO Shipping Holdings (01919) repurchased 3 million shares at a cost of approximately HKD 41.8218 million on December 4 [2] - Kuaishou-W (01024) repurchased 445,000 shares for approximately HKD 29.923 million on December 4 [2] - China Feihe (06186) repurchased 6.281 million shares at a cost of approximately HKD 25.7521 million on December 4 [2] - Kingsoft (03888) repurchased 355,600 shares for approximately HKD 9.99756 million on December 4 [2] - Weimob Group (02013) saw its chairman Sun Taoyong increase his holdings by a total of 1.534 million shares [2] - Green Tea Group (06831) plans to repurchase shares for a total price not exceeding RMB 130 million [2] Operating Performance - Greentown China (03900) reported total contract sales of approximately RMB 223.5 billion for the first 11 months, a year-on-year decrease of 9.44% [2] - China Overseas Macro Group (00081) reported cumulative contract sales of RMB 29.615 billion for the first 11 months, down 16.6% year-on-year [3] - China Overseas Development (00688) reported cumulative property sales of approximately RMB 211.399 billion for the first 11 months, a year-on-year decrease of 21.8% [3] - Sunac China (01918) achieved contract sales of approximately RMB 33.89 billion for the first 11 months, down 25.34% year-on-year [3] - Gemdale Corporation (00535) reported cumulative contract sales of approximately RMB 9.874 billion for the first 11 months, a year-on-year decrease of 43.5% [3] - Hongyang Real Estate (01996) reported cumulative contract sales of RMB 4.181 billion for the first 11 months, down 47.87% year-on-year [3] - Country Garden (02007) reported contract sales of approximately RMB 2.35 billion in November attributed to shareholders [3]

Core Viewpoint - The company Shijiazhuang Yiling Pharmaceutical Group (stock code: 02005) has received approval from the National Medical Products Administration of China for its active pharmaceutical ingredients, Bilastine and Picoplatin Sodium, to be used in marketed formulations [1] Group 1 - Bilastine is primarily used for the symptomatic treatment of urticaria [1] - Picoplatin Sodium is mainly used for bowel cleansing prior to surgical procedures such as colonoscopy [1]

Core Viewpoint - The company Shijiazhuang Yiling Pharmaceutical Group (stock code: 02005) has received approval from the National Medical Products Administration of China for its active pharmaceutical ingredients Bilastine and Picoplatin Sodium to be used in marketed formulations [1] Group 1 - Bilastine is primarily used for the symptomatic treatment of urticaria [1] - Picoplatin Sodium is mainly used for bowel cleansing prior to surgical procedures such as colonoscopy [1]

本公告為本公司自願發佈，目的是使股東及潛在投資者瞭解本集團最新業務發展情況。 承董事局命 執行董事兼公司秘書 香港，二零二五年十二月四日 於本公告日期，董事局成員包括執行董事曲繼廣先生、蘇學軍先生、孟國先生、周興揚先生及 曲婉蓉女士，非執行董事劉文軍先生，以及獨立非執行董事王亦兵先生、周國偉先生及姜廣策 先生。 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之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不會就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致之任何損失承擔任何責任。 自願公告 產品開發的最新進展 石四藥集團有限公司（「本公司」，連同其附屬公司，「本集團」）董事局（「董事局」）欣然公告， 本集團的比拉斯汀及匹可硫酸鈉已獲中國國家藥品監督管理局批准登記成為在上市製劑使用 的原料藥。比拉斯汀主要用於蕁麻疹的對症治療，而匹可硫酸鈉主要用於結腸鏡等外科手術檢 查前的結腸清潔。 周興揚 ...