Core Viewpoint - The successful imitation of the kidney disease drug Nefukang (Budesonide enteric-coated capsules) has led to a significant decline in the stock price of CloudTop New Medicine (01952.HK), which has dropped over 20% in the past week due to concerns over competition from generic drug manufacturers [2]. Group 1: Company Overview - Nefukang, introduced by CloudTop New Medicine in June 2019, received approval from the Chinese National Medical Products Administration in November 2023 for treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [4]. - The product achieved sales exceeding 1 billion yuan in the first three quarters of 2025 [4]. Group 2: Patent and Competition - CloudTop New Medicine asserts that the patent for Nefukang is valid until May 7, 2029, and the company reserves the right to take legal action against any infringement [2]. - The first generic version of Budesonide enteric-coated capsules was approved for Hainan Huirui Pharmaceutical Co., Ltd. on December 16, 2025, with a commitment to not market the generic until the patent expires [5]. - Other companies, including Shijiazhuang Yiling Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd., are also in the process of developing generic versions, potentially allowing them to enter the market before the patent expiration [6]. Group 3: Legal and Regulatory Framework - The early resolution mechanism for drug patent disputes aims to balance the interests of original drug manufacturers and generic drug developers, promoting high-level development of generic drugs while protecting innovation [7]. - CloudTop New Medicine can challenge the patent declarations of Shijiazhuang Yiling and Qilu within 45 days of the public announcement of their drug applications [8]. - The case is seen as a test of China's drug patent linkage system, with implications for how administrative and judicial bodies balance the interests of original and generic drug manufacturers [9].

Core Viewpoint - The article discusses the impact of successful generic drug approvals on the stock price of Cloudtop New Yao (01952.HK), particularly focusing on the generic version of its drug, Neficon (Budesonide Enteric-Coated Capsules), which has led to a significant decline in the company's stock price by over 20% in the past week [3][6]. Group 1: Drug Approval and Market Impact - Neficon, introduced by Cloudtop New Yao in June 2019, received approval from the Chinese National Medical Products Administration in November 2023 for treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [6]. - The sales of Neficon exceeded 1 billion yuan in the first three quarters of 2025, indicating strong market performance [6]. - The approval of a generic version by Hainan Huirui Pharmaceutical on December 16, 2025, has raised concerns for Cloudtop New Yao, as it may lead to increased competition [6][7]. Group 2: Patent and Legal Considerations - Cloudtop New Yao maintains that its patent for Neficon is valid until May 7, 2029, and reserves the right to take legal action against any infringement [3][7]. - Hainan Huirui's patent declaration type is classified as "Category 3," indicating a commitment not to market the generic drug until the relevant patent expires [7]. - Other companies, such as Shijiazhuang Yiling Pharmaceutical and Qilu Pharmaceutical, are also in the process of developing generic versions, with their patent declarations classified as "Category 4.2," suggesting they may not infringe on the original patent [8]. Group 3: Response Strategies - Cloudtop New Yao is considering its options in response to potential challenges from generic competitors, emphasizing the need for clinical studies to confirm the efficacy and safety of any generic versions [10]. - The article highlights the importance of the early resolution mechanism for drug patent disputes established by the National Medical Products Administration and the National Intellectual Property Administration, which aims to balance interests between original and generic drug manufacturers [10][11]. - Legal experts suggest that Cloudtop New Yao has a 45-day window to challenge the patent declarations of generic applicants in court, which could influence the market dynamics [11][12].

Core Viewpoint - The approval of a generic version of the nephrology drug Neficon (Budesonide Enteric Capsules) has led to a significant decline in the stock price of Cloudy New Horizon (01952.HK), which has dropped over 20% in the past week due to concerns over competition from generic manufacturers [2]. Group 1: Company Overview - Neficon, introduced by Cloudy New Horizon in June 2019, received approval from the Chinese National Medical Products Administration in November 2023 for treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [4]. - The product achieved sales exceeding 1 billion yuan in the first three quarters of 2025 [4]. - The original patent for Neficon is valid until May 7, 2029, and the company retains the right to take legal action against any infringement [2][5]. Group 2: Generic Competition - Hainan Huirui Pharmaceutical Co., Ltd. has successfully obtained approval for its generic Budesonide Enteric Capsules, with a patent declaration type of "Category 3," promising not to market the generic until the relevant patent expires [5]. - Other companies, including Shijiazhuang Yiling Pharmaceutical Co., Ltd. and Qilu Pharmaceutical Co., Ltd., are also in the process of developing generic versions, with their patent declarations classified as "Category 4.2," indicating they may not infringe on the original patent [5][6]. - If these companies succeed in obtaining approval, they could potentially launch their products before the original patent expiration date [5]. Group 3: Legal and Regulatory Framework - The early resolution mechanism for drug patent disputes, established by the National Medical Products Administration and the National Intellectual Property Administration, aims to balance interests between original and generic drug manufacturers [6][8]. - Cloudy New Horizon can challenge the patent declarations of Shijiazhuang and Qilu within 45 days of the public announcement of their drug applications [7]. - The case is seen as a test of the new patent linkage system in China, which seeks to protect innovation while promoting the development of high-quality generics [8][9].

Core Viewpoint - The successful generic challenge to the kidney disease drug Nefukang (Budesonide Enteric Capsules) by competitors has led to a significant decline in the stock price of CloudTop New Drug (01952.HK), which has dropped over 20% in the past week [1] Group 1: Company Overview - Nefukang, introduced by CloudTop New Drug in June 2019 and approved for market in November 2023, is aimed at treating adult patients with primary IgA nephropathy at risk of progression, filling a treatment gap in China [3] - The drug achieved sales exceeding 1 billion yuan in the first three quarters of 2025 and was included in China's medical insurance reimbursement list [3] Group 2: Patent and Generic Drug Challenges - The patent for Nefukang is valid until May 7, 2029, and CloudTop New Drug retains the right to take legal action against any infringement [1] - Competitors, including Hainan Huirui Pharmaceutical, Shijiazhuang Yiling Pharmaceutical, and Qilu Pharmaceutical, are also in the process of developing generic versions of Budesonide Enteric Capsules, with Hainan Huirui already receiving approval [4][5] - Hainan Huirui's patent declaration type is "Category 3," promising not to market the generic until the relevant patent expires, while Shijiazhuang and Qilu's declarations are "Category 4.2," indicating their generics may not infringe on existing patents [4][6] Group 3: Regulatory and Legal Framework - The early resolution mechanism for drug patent disputes aims to balance interests between original drug manufacturers and generic drug developers, promoting high-level development of generics while protecting innovation [6][8] - CloudTop New Drug can challenge the patent declarations of Shijiazhuang and Qilu within 45 days of the public announcement of their drug applications [7] - The case is seen as a potential test of China's drug patent linkage system, with implications for how administrative and judicial bodies balance the interests of original and generic drug manufacturers [8]

Core Viewpoint - The innovative pharmaceutical company, YunTing XinYao, is actively defending its patent for Budesonide enteric-coated capsules (NaiFuKang) against a newly approved generic version by Hainan HeRui Pharmaceutical, asserting that its patent is valid until May 7, 2029 [1][5]. Group 1: Patent and Legal Dispute - YunTing XinYao has announced its intention to take legal action against any infringement of its patent rights related to NaiFuKang, which is currently under effective patent protection in China [1]. - Hainan HeRui's Budesonide enteric-coated capsules received approval on December 16, 2023, raising concerns about potential patent infringement [1][4]. - The legal discourse includes a distinction between "Category 3" and "Category 4" declarations made by generic drug applicants, with Hainan HeRui opting for a "Category 3" declaration, indicating an acknowledgment of the existing patent [5][6]. Group 2: Market Impact and Sales Projections - NaiFuKang is projected to achieve sales between 12 billion to 14 billion yuan in 2025, with expectations to reach 24 billion to 26 billion yuan in 2026, following its inclusion in the medical insurance negotiations [2]. - The drug is specifically designed for treating primary IgA nephropathy, a serious condition affecting a significant number of young adults in China, with approximately 30,000 new cases annually [2][3]. Group 3: Drug Mechanism and Innovation - The unique formulation of NaiFuKang utilizes a dual-release technology that targets the drug delivery to the ileum, significantly delaying kidney function decline and providing renal protection [4]. - Unlike traditional treatments that only alleviate symptoms, NaiFuKang represents a fundamental shift in the treatment of IgA nephropathy by addressing the underlying disease mechanism [3][4]. Group 4: Clinical and Regulatory Considerations - YunTing XinYao has raised concerns regarding the adequacy of conventional bioequivalence tests for generic versions of NaiFuKang, suggesting that clinical efficacy and safety need to be confirmed through large-scale studies [7]. - The approval of Hainan HeRui's generic version may intensify competition in the IgA nephropathy treatment market, potentially impacting YunTing XinYao's market position [7].

Core Viewpoint - The recent announcement of the 11th batch of national centralized procurement results highlights that Nanjing Fangsheng and its drug, Tangjing (Dapagliflozin Tablets), have successfully won the bid, showcasing the company's strength and enhancing its brand influence [1] Group 1: Company Overview - Dapagliflozin Tablets are SGLT-2 inhibitors primarily used for improving blood sugar control in adult patients with type 2 diabetes [1] - The drug was approved for entry into China in 2017, with its national patent set to expire in March 2028 [1] - Fangsheng Medicine has received approval for a total of 8 drug products, with multiple applications pending and over 20 pipelines in research, alongside nearly 50 authorized patents [1] Group 2: Market Impact - The successful bid in the national procurement reflects the company's capabilities and is expected to facilitate the entry of its drugs into more medical terminals across the country [1] - This achievement is anticipated to motivate the company to continue focusing on its mission of making quality medications more accessible to patients, further deepening its engagement in the biopharmaceutical field [1]

Core Viewpoint - China emphasizes the importance of intellectual property protection as a key component of a market-oriented, law-based, and international business environment [1] Group 1: Intellectual Property Protection - The Vice President of the National Intellectual Property Administration of China, Hu Wenhui, highlighted the country's commitment to intellectual property protection during a meeting with representatives from the International Pharmaceutical Enterprises Alliance (INTERPAT) [1] - The National Intellectual Property Administration is open to maintaining good communication with the industry and is willing to listen to suggestions from foreign enterprises regarding intellectual property development in China [1] Group 2: Industry Collaboration - Discussions included mechanisms for early resolution of pharmaceutical patent disputes, the submission of supplementary experimental data for drug patents, and the compensation system for drug patent terms [1]

Core Insights - China has approved the injection of Acetate Degarelix (brand name: Qinglishu) developed by Chengda Tianqing Pharmaceutical Group for prostate cancer patients requiring androgen deprivation therapy, providing a new treatment option for over 100,000 patients annually [1][2] - The drug has already been approved in the EU and received temporary approval in the US, marking it as the first generic version globally [1][3] - Chengda Tianqing successfully challenged two core patent claims of the original drug, allowing the product to gain a "12-month exclusivity period" under China's early resolution mechanism for drug patent disputes [1][4] Industry Context - Prostate cancer is the second most common cancer among men globally, with 1.5 million new cases and nearly 400,000 deaths reported in 2022 [2] - In China, the incidence of prostate cancer has been rising, with 134,200 new cases in 2022, often diagnosed at advanced stages due to subtle early symptoms [2] - Acetate Degarelix acts as a GnRH receptor antagonist, reducing the release of gonadotropins and testosterone, and is recommended in major treatment guidelines since its US launch in 2008 [2][3] Product Development - The development of Acetate Degarelix involved overcoming significant technical challenges in formulation and raw material development, with Chengda Tianqing achieving compliance with US and EU standards [3] - The product's current prices under medical insurance are 2,046 yuan (for 120mg, 2 vials) and 750 yuan (for 80mg, 1 vial), which is expected to provide a more affordable option for patients compared to the original drug [3][4] Patent Challenge and Market Impact - The drug is the second to receive a "12-month exclusivity period" under China's drug patent linkage system, which aims to balance the interests of innovative and generic drug companies [4][5] - Chengda Tianqing's successful patent challenges are expected to enhance market competition and significantly reduce patient costs, as seen with their previous product, Everolimus tablets, which were priced over 500 yuan lower than the original [5]