Core Viewpoint - The pharmaceutical company YunTing XinYao is actively defending its patent rights for its core product Budesonide Enteric Capsules (NaiFuKang) against the approval of a generic version by Hainan HeRui Pharmaceutical, asserting that its patent is valid until May 7, 2029 [2][9]. Company Summary - YunTing XinYao's stock price is currently at HKD 44.62, with a market capitalization of HKD 15.775 billion [2]. - The company has announced its intention to take legal action against any infringement of its patent rights regarding NaiFuKang [2][10]. Industry Summary - The approval of Hainan HeRui's Budesonide Enteric Capsules on December 16, 2023, may significantly impact the market for IgA nephropathy treatments, as NaiFuKang is the only approved drug targeting this condition in China [6][9]. - The sales forecast for NaiFuKang is projected to reach between CNY 12 billion to CNY 14 billion in 2025, and CNY 24 billion to CNY 26 billion in 2026 [6]. - The mechanism of action for NaiFuKang involves a unique dual-release formulation that targets the ileum, which is expected to provide renal function protection for IgA nephropathy patients [8]. Patent and Legal Dispute Summary - Hainan HeRui submitted a "Category 3 Declaration" when applying for the generic drug, indicating an acknowledgment of YunTing XinYao's patent and a commitment not to market the generic until the patent expires [9][10]. - The legal discourse centers around the implications of the "Category 3 Declaration" versus a "Category 4 Declaration," which challenges the validity of the patent [10][11]. - Other companies, such as Qilu Pharmaceutical and Shijiazhuang Yiling Pharmaceutical, have submitted applications with "Category 4 Declarations," indicating a more aggressive stance against YunTing XinYao's patent [11]. Market Impact Summary - Following the news of the generic approval, YunTing XinYao's stock experienced a decline of 8.98% over three trading days [12]. - The increasing number of approved generic drugs in the IgA nephropathy market is expected to intensify competition [12].

Core Viewpoint - The company, Genting New Year (01952.HK), has noted the approval of a generic version of its patented product Budesonide Enteric Capsules (耐赋康®) by the National Medical Products Administration of China, while emphasizing the protection of its original product under a valid patent until May 7, 2029 [1] Group 1 - The company’s original product,耐赋康®, is protected by patent ZL200980127272.5, which is currently valid [1] - The patent rights will expire on May 7, 2029, and the company has registered relevant patent information on the Chinese drug patent information registration platform [1] - According to Chinese patent law, any entity or individual must obtain legal permission from the company before manufacturing, using, or selling products that fall under the patent protection before its expiration [1] Group 2 - The company reserves the right to take legal action against any infringement of the patent rights or violations of commitments made by generic drug applicants [1] - Generic drug applicants must adhere to their commitments if they submit a "Category 3 Declaration," promising not to market the drug before the patent expires [1]

Core Viewpoint - The company has noted the approval of a generic version of its product Budesonide Enteric-Coated Capsules (耐赋康®) by the National Medical Products Administration of China, while emphasizing the protection of its original product under a valid patent until May 7, 2029 [1] Group 1 - The company holds a patent (ZL200980127272.5) for its original product in China, which is currently valid [1] - The patent information has been registered with the Chinese drug patent information registration platform [1] - According to Chinese patent law, any entity or individual must not manufacture, use, promise to sell, or import products that fall under the patent protection without the company's legal permission before the patent expires [1] Group 2 - The company reserves the right to take legal action against any infringement of the patent or violations of commitments made by generic applicants [1] - Generic applicants must adhere to their commitments if they submit a "Category 3 Declaration," promising not to market the drug before the patent expiration [1]

Core Viewpoint - The company has noted the approval of a generic version of its patented product Budesonide Enteric-Coated Capsules (Nafacon®) by the National Medical Products Administration of China, while emphasizing the protection of its original product under a valid patent until May 7, 2029 [1] Group 1 - The company holds a valid patent (ZL200980127272.5) for Nafacon® in China, which is registered on the national drug patent information platform [1] - According to Chinese patent law, any entity or individual must not manufacture, use, promise to sell, or import products within the patent protection scope without the company's permission before the patent expires, or it will constitute patent infringement [1] - The company reserves the right to take legal action against any infringement of the patent rights and commitments made by generic drug applicants [1] Group 2 - The company is committed to introducing breakthrough therapies to China to meet significant medical needs, highlighting the importance of a robust patent protection system for the sustainable accessibility of innovative drugs [2] - The improving intellectual property protection environment in China's pharmaceutical industry provides strong support for innovation and healthy industry development [2] - The company aims to continue collaborating with various parties to respect and uphold intellectual property rights, fostering a fair competitive environment for the ongoing development of innovative drugs [2]

Group 1 - The board of directors of the company noted the approval of a generic version of its patented product Budesonide Enteric-Coated Capsules (耐赋康®) by the National Medical Products Administration of China [1] - The original product is protected by patent ZL200980127272.5, which is valid until May 7, 2029, and the company has registered this information on the Chinese drug patent information registration platform [1] - According to Chinese patent law, any entity or individual must not manufacture, use, promise to sell, or import products within the patent protection scope without the company's legal permission before the patent expires, or it will constitute patent infringement [1] Group 2 - The company is committed to introducing breakthrough therapies to China to meet urgent medical needs, emphasizing the importance of a robust patent protection system and effective regulations for the sustainable accessibility of innovative drugs [2] - The environment for intellectual property protection in China's pharmaceutical industry has been continuously optimized, providing strong support for pharmaceutical innovation and healthy industry development [2] - The company will continue to collaborate with various parties to respect and uphold intellectual property rights, adhere to relevant laws and regulations, and foster a fair competitive environment to promote the ongoing development and accessibility of innovative drugs for the benefit of Chinese patients [2]

Group 1 - The company has noted the approval of a generic version of its proprietary product Budesonide Enteric-Coated Capsules (Nafukang) by the National Medical Products Administration of China [1] - The original product Nafukang is protected by patent ZL200980127272.5, which is valid until May 7, 2029, and the company has registered this patent information on the Chinese drug patent information registration platform [1] - According to Chinese patent law, any entity or individual must not manufacture, use, promise to sell, sell, or import products that fall under the patent protection without the company's legal permission before the patent expires, or it will constitute patent infringement [1] Group 2 - The company is committed to introducing breakthrough therapies to China to meet urgent medical needs, emphasizing the importance of a robust patent protection system and effective regulations for the sustainable accessibility of innovative drugs [2] - The environment for intellectual property protection in China's pharmaceutical industry has been continuously optimized, providing strong support for pharmaceutical innovation and healthy industry development [2] - The company will continue to collaborate with various parties to respect and uphold intellectual property rights, adhere to relevant laws and regulations, and foster a fair competitive environment to promote the ongoing development and accessibility of innovative drugs for the benefit of Chinese patients [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，概不對因本公告全部或任何部份內容而產生或因倚賴該 等內容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立的有限公司） （股份代號：1952） Everest Medicines Limited 雲 頂 新 耀 有 限 公 司 自願公告 本公告由雲頂新耀有限公司（「本公司」）自願作出。 本公司董事（「董事」）會（「董事會」）注意到有針對本公司上市許可產品布地奈德腸溶 膠囊（耐賦康®）的仿製藥品的上市許可在中國獲得中國國家藥品監督管理局批准。 董事會強調本公司原研產品耐賦康®的相關技術在中國受到專利ZL200980127272.5的 保護，該專利目前處於有效狀態，其專利權有效期直至2029年5月7日屆滿。本公 司已依法將該專利相關資訊登記於中國上市藥品專利資訊登記平台。 根據中國《專利法》第11條及《藥品專利糾紛早期解決機制實施辦法（ 試行 ）》（「該辦 法」）的相關規定，任何企業或個人除非經本公司合法許可，不得在上述專利期限 屆滿前為生產經營目的製造、使用、許諾銷售（ 包括市場推廣、申請 ...

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 core management team and major shareholders of Everest Medicines (01952.HK) collectively purchased over HKD 38 million worth of company shares, signaling strong confidence in the company's future prospects [1][2][17]. Group 1: Share Purchase Details - Total amount of shares purchased exceeded HKD 38 million [1][17]. - Average purchase price was approximately HKD 45.01 per share [2][6]. - Key shareholders, including Kangqiao Capital, have committed to potentially increasing their stake by up to 1% over the next three to six months [2][24]. Group 2: Market Reaction and Management Confidence - Following the announcement of the share purchases, the company's stock price rose by over 4% on the next trading day [2][17]. - The board of directors stated that this action reflects the management's and major shareholders' confidence in the company's long-term development [2][23]. Group 3: Key Executive Involvement - Notable executives involved in the share purchase include CFO He Ying, who spent approximately RMB 4 million to acquire around 98,159 shares, representing about 16% of his annual salary of RMB 25 million [3][9][25]. - Other executives, including the chairman and CEO, also participated in the share buyback [5][21].

Core Viewpoint - The company has noted the approval of a generic version of its marketed product Budesonide Enteric-Coated Capsules (Nafacon) [1] Group 1 - The original product Nafacon is protected by patent ZL200980127272.5 in China, which is currently valid until May 7, 2029 [1] - The company reserves the right to take legal action against any infringement of the patent rights and commitments [1]