21世纪经济报道记者 李佳英 广州报道 既然已晚人一步，为什么石药选择专利挑战而非切换分子？有业内人士分析，此举折射出国内创新药企的竞争升级，从国内市 场厮杀转向全球专利博弈，尤其在GLP-1这类千亿级赛道争夺窗口期。目前USPTO尚未裁决，但结果可能引发连锁反应。 "若歌礼胜诉，将巩固其技术护城河；若石药弯道超车，或为后续类似案例打开闸门，优先选择专利挑战以此测试对手专利壁垒 的强度。"该业内人士指出。 专利战狭路相逢 此次专利争议的核心在于石药集团正在申请的一项化合物（Compound 10，申请号：PCT/CN2024/140920）与歌礼已获授权的化 合物1（Compound 1）分子结构完全一致。 四川省技术转移中心主管药师李博指出，生物医药专利主要包括新化合物专利、制剂与制药工艺专利、用途专利及生物技术专 利。在这些类型中，新化合物专利因技术壁垒高、研发成本高，是跨国授权的核心内容。同时，专利权的排他性使其在跨国授 权时需对技术控制范围进行明确限制，以平衡技术扩散与权利保护。 歌礼制药强调，该专利基于其专有技术，并已通过USPTO的严格审查，于2025年2月25日正式授权，具备充分的新颖性和创新 ...

石药尚在专利申请中的化合物10（Compound 10，申请号：PCT/CN2024/140920；申请人：石药集团百 克（山东）生物制药股份有限公司（CSPC Baike (Shandong)Biopharmaceutical Co., Ltd.））与歌礼已获 USPTO授权的该专利所涵盖的化合物1(Compound 1)分子结构完全一致。 但歌礼向USPTO提交专利申请的日期领先石药申请的日期长达三个多月之久，截至本公告日期，石药 的专利申请仍在审查中。 近日，歌礼制药发布自愿性公告。披露公司近日获悉由石药集团有限公司附属公司康久普乐生物医疗有 限公司向美国专利商标局（「USPTO」）提交的一项复审。该复审质疑本公司附属公司歌礼制药（中 国）有限公司一项已获授权的美国专利的有效性。截至本公告日期，该复审仍在USPTO审查中。 本公司对于该专利的有效性充满信心，如该复审继续推进，本公司将采取一切必要的法律手段扞卫本公 司的知识产权。 由于该复审目前仍在USPTO审查中，当前阶段该复审对本集团无潜在影响。本公司将密切关注该复审 的进展并评估其影响，与此同时，当前本公司的业务及运营未受影响。 （企业公告） 尽管 ...

Core Viewpoint - The article discusses the ongoing patent dispute between Songlei and Conjupro Biotherapeutics, a subsidiary of CSPC Pharmaceutical Group, regarding the validity of a US patent held by Songlei, which is currently under review by the USPTO [1][3]. Group 1: Patent Dispute Details - On June 30, Songlei announced that it was informed on June 24 about Conjupro's request for a Post Grant Review at the USPTO, questioning the validity of specific claims in Songlei's US patent (Patent No: 12,234,236) [1]. - Conjupro's application for "Compound 10" is claimed to be structurally identical to Songlei's "Compound 1," with Songlei asserting that its patent application was submitted over three months prior to Conjupro's [1]. - As of the announcement, the review request is still under examination by the USPTO [1]. Group 2: Background and Implications - Songlei noted that it could not ascertain the specific reasons behind Conjupro's review request, but highlighted that Conjupro had previously sought global licensing discussions for the GLP-1R agonist Compound 1, which Songlei declined [3]. - The patent in question is based on proprietary technology developed by Songlei and is currently being utilized in the development of the candidate drug ASC30, with multiple related molecules protected under various patent systems [4]. - The USPTO officially granted the patent rights to Songlei on February 25, 2025, citing its innovation and non-obviousness compared to existing technologies [4].

该专利系利用歌礼专有技术开发而成，目前正应用于公司候选药物ASC30的研发。公司包括化合物1和 ASC30在内的化合物受多项专利保护，包括前述该专利。基于其与现有技术相比具有新颖性和非显而易 见性，USPTO已于2025年2月25日将该专利权授予公司附属公司歌礼制药(中国)有限公司。 公司对于该专利的有效性充满信心，如该复审继续推进，公司将采取一切必要的法律手段捍卫公司的知 识产权。 由于该复审目前仍在USPTO审查中，当前阶段该复审对集团无潜在影响。公司将密切关注该复审的进 展并评估其影响，与此同时，当前公司的业务及运营未受影响。 智通财经APP讯，歌礼制药-B(01672)发布公告，该公司董事会于2025年6月24日获悉由石药集团有限公 司(一家于香港联合交易所有限公司上市的公司，股份代号：1093)附属公司康久普乐生物医疗有限公司 (Conjupro Biotherapeutics, Inc.)向美国专利商标局(USPTO)提交的一项复审。该复审质疑公司附属公司歌 礼制药(中国)有限公司一项已获授权的美国专利(美国专利号：12,234,236)权利要求 1-9、12-17及21-25 的有效性。截至本公 ...

Core Viewpoint - The company's ASC30 and ASC47 drugs showcased at the ADA conference have promising future prospects, with ASC30 demonstrating good pharmacokinetic characteristics and safety, while ASC47 shows potential for fat reduction and muscle gain in preclinical studies [1][2]. Event Summary - On June 18, the company announced the completion of the first dosing of subjects in the U.S. Phase I clinical trial for ASC50, an oral small molecule IL-17 inhibitor for psoriasis [1]. - On June 23, ASC30 and ASC47 were presented at the ADA conference, highlighting their clinical research data [1]. ASC30 Insights - The SAD study for ASC30 included 30 subjects divided into five groups with doses of 2mg, 5mg, 10mg, 20mg, and 40mg, showing a half-life of 30-55 hours for the 5-40mg groups, indicating favorable pharmacokinetic properties [1][2]. - The study reported that all side effects were mild to moderate, with no vomiting in the 2mg and 5mg groups, confirming the drug's controllable safety profile [2]. ASC47 Insights - Preclinical studies of ASC47 indicated its potential for fat reduction, muscle gain, and weight loss, particularly when combined with semaglutide in mouse models, showing a greater weight loss trend compared to the semaglutide-only group [2]. ASC50 Potential - ASC50 is positioned as a promising oral treatment for psoriasis, currently undergoing Phase I clinical trials in the U.S. The preclinical data suggest higher oral exposure, longer half-life, and strong efficacy, supporting its potential as a best-in-class oral medication [2]. Future Development Outlook - The company plans to continue advancing its core pipeline, with ASC30's oral Phase IIa study and ASC40's Phase III study expected to be completed by 2025, alongside the publication of ASC30's subcutaneous Phase Ib results [3]. - The focus remains on ASC30 and ASC47, with multiple pipeline developments anticipated in the coming years [3]. Financial Forecast - The core drugs ASC30 and ASC47 are in early development stages, showing excellent safety and efficacy in early clinical results. The company estimates a reasonable market value of HKD 19.29 billion, raising the target price to HKD 19.93, maintaining a "buy" rating [3].

China (PRC) | Healthcare Equity Research China Force in ADA 2025 All eyes on ADA'25 with key presentations during this weekend, e.g.LLY's Orfo and Bima. China biotechs will also have a presence with notable data to watch: 1) Ascletis's ASC30 (orfo-structure oral GLP-1) in Ph1, 2) Laekna's LAE102 (muscle preserving) in Ph1 and 3) Innovent's Mazdutide (GLP-1/ GCG) Ph3 data in T2D. We don't anticipate major surprises from China in ADA'25 though given oral GLP-1 and amylin candidates in early stages and no key ...

Core Insights - Ascletis Pharma Inc. has initiated a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting interleukin-17 (IL-17), aimed at treating psoriasis [2][3] - The trial is randomized, double-blind, and placebo-controlled, involving both healthy participants and patients with mild-to-moderate plaque psoriasis [3] - Preclinical data suggests that ASC50 has higher oral exposure, a longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [1] Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing innovative therapeutics for metabolic diseases [4] - The company utilizes its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) Platform and Ultra-Long-Acting Platform (ULAP) to develop drug candidates in-house [4] - Ascletis is listed on the Hong Kong Stock Exchange under the ticker 1672.HK [4]

消息面上，歌礼制药近日公布，同类首创、每日一次口服小分子脂肪酸合成酶(FASN)抑制剂地尼法司 他(ASC40)治疗中重度寻常性痤疮的III期临床试验(NCT06192264)达到所有主要、关键次要及次要终 点。东吴证券指出，目前痤疮疗法治标不治本，而地尼法司他III期临床达到所有终点，疗效数据优秀， 未来有望成为疗效显著、患者依从性高、安全性好的BIC痤疮药物。随着地尼法司他III临床期顺利结 束，公司预计将在2025年提交药监局申报上市，2026年贡献收入。 此外，歌礼制药将在美国芝加哥举行的美国糖尿病协会(ADA)第85届科学会议上，以壁报形式报告口服 小分子GLP-1受体(GLP-1R)激动剂ASC30，以及脂肪靶向、减重不减肌候选药物ASC47的早期研究数 据。东吴证券指出，ASC30是目前唯一一款既可每天口服，也可每月一次皮下注射的GLP-1小分子，满 足了不同市场人群的需求，具备稀缺性；ASC47是靶向脂肪细胞THRβ靶点的小分子药物，每月一次皮 下注射，有减脂不减肌潜力，是首个THRβ靶点的小分子减肥药。目前I期SAD研究数据已读出，在美国 联合司美格鲁肽临床研究已经完成首例患者给药。 智通财 ...

Core Insights - Ascletis Pharma Inc. is set to present preliminary studies on its oral GLP-1 receptor agonist ASC30 and weight loss drug candidate ASC47 at the 85th Scientific Sessions of the American Diabetes Association in Chicago [1][5] Group 1: ASC30 - ASC30 is an investigational GLP-1 receptor biased small molecule agonist that can be administered both orally and via subcutaneous injection [3] - It is a new chemical entity with patent protection in the U.S. and globally until 2044 [3] - The first-in-human single ascending dose study will be presented under poster number 750-P on June 22, 2025 [2] Group 2: ASC47 - ASC47 is an adipose-targeted, ultra-long-acting small molecule agonist that selectively targets thyroid hormone receptor beta [4] - It is designed to achieve high drug concentrations in adipose tissue, demonstrating unique properties for obesity treatment [4] - The ongoing Phase I clinical trial in combination with semaglutide for obesity treatment began dosing participants in May 2025 [4][2] Group 3: American Diabetes Association (ADA) - The ADA is a leading nonprofit organization focused on diabetes prevention, cure, and improving the lives of those affected by diabetes [5] - The 85th Scientific Sessions will take place from June 20 to 23, 2025, in Chicago, setting the agenda for clinical practice and research innovation [5] Group 4: Ascletis Pharma Inc. - Ascletis is an innovative R&D-driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases [6] - The company covers the entire value chain from drug discovery and development to GMP manufacturing [6] - Ascletis has multiple clinical-stage drug candidates in its metabolic disease pipeline, addressing unmet medical needs globally [7]

证券研究报告 东吴证券晨会纪要 东吴证券晨会纪要 2025-06-06 [Table_Tag] 宏观策略 [Table_MacroStrategy] 宏观深度报告 20250603：复盘 200 年，贸易战何去何从？ 通过复盘自 1800 年至今 200 余年的全球贸易历史，以及结合近期东部沿 海省份"造船厂-船东-船公司-货代及外贸公司-实体制造业"外贸产业链 调研反馈，我们的研究表明： 首先，复盘全球贸易历史看，汇率、非关 税壁垒可能取代关税成为更加关键的"贸易交锋"工具。 其次，国内多 数外贸企业认为由于在根本矛盾上的冲突，中美贸易谈判过程未来或将 "一波三折"，企业可能需要持续控制对美出口风险敞口。 再次，如果加 征关税无法实现美方贸易竞争的主要目的，那么参考过去 200 年全球贸 易历史特别是 1970s-1990s 美日德贸易竞争阶段的美方举措，未来美国政 府可能在非关税壁垒、汇率等方面发起更多挑战。 最后，在控制对美出 口风险敞口的过程中，拓展非美出口、"出口转内销"、"出海"等关键手 段仍待企业端摸索落地方式，年内外贸前景仍面临高度不确定性。 宏观深度报告 20250602：人民币汇率：会否升 ...