Group 1 - CSF-1R highly selective small molecule Pimitinib has been approved for the treatment of symptomatic adult patients with tenosynovial giant cell tumor (TGCT) that may lead to functional limitations or serious complications after surgical resection [1] - Pimitinib is the company's first self-developed innovative drug product, demonstrating good efficacy and safety [1] - The MANEUVER III phase study showed an overall response rate (ORR) of 54.0% at 25 weeks for patients treated with Pimitinib, increasing to 76.2% at a median follow-up of 14.3 months [1] Group 2 - Patients who switched to Pimitinib from the control group also experienced clinical benefits, with an ORR of 64.5% at a median follow-up of 8.5 months [2] - Pimitinib has a higher ORR compared to existing drugs like Pexidartinib and Vimseltinib, which have ORRs of 39% and 40% respectively, and Pimitinib does not carry the risk of cholestatic liver toxicity [2] - The global commercialization process for Pimitinib is accelerating, with approvals in China and recognition from the FDA and EMA for breakthrough therapy designation and priority medicine status [2] Group 3 - ABSK043 is designed for combination therapy and is currently undergoing three phase II clinical trials in conjunction with other treatments [3] - The most common driver gene mutation in non-small cell lung cancer (NSCLC) is the EGFR mutation, and third-generation EGFR-TKIs have become the standard first-line treatment [3] - Previous studies indicate that the efficacy of third-generation EGFR-TKIs is inferior in patients with high PD-L1 expression compared to those with low or negative expression [3] Group 4 - In a phase II clinical trial of ABSK043 combined with Vemurafenib, the disease control rate (DCR) reached 71% and the ORR was 25% among patients with EGFR mutations and positive PD-L1 [4] - The company has a robust pipeline with over 10 clinical-stage oncology products, including the Pan-KRAS inhibitor ABSK211 expected to enter clinical stages by 2026 [4] - Revenue forecasts for the company are projected at 630 million, 685 million, and 637 million yuan for 2025-2027, with net profits expected to be 45 million, 70 million, and 102 million yuan respectively [4]

晨会纪要 证券研究报告 2025 年 12 月 31 日 核心结论 分析师 【策略】资产的信号（20251230）：人民币升值是 2026 繁荣的契机 短期看，大量的待结汇资金和跨境资本有望随人民币升值加速结汇/回流， 强化人民币升值趋势，中长期看，中国强大的工业实力带来的出口竞争力是 人民币升值的根本动力。跨境资本回流叠加化债政策空间打开，实体现金流 量表和资产负债表有望依次修复，2026 年中国有望迎来繁荣的起点。大类 资产继续坚定看好 AH 股/国债等人民币资产，黄金保持战略配置，但对投机 交易保持谨慎，工业金属关注铜、铝、镍等品种，美股&美债或维持震荡。 【银行】寰宇通汇系列八：数字人民币将实现 M0 向 M1 的重要跨越 央行出台《关于进一步加强数字人民币管理服务体系和相关金融基础设施建 设的行动方案》，宣布新一代数字人民币体系将于 2026 年 1 月 1 日正式启 动实施。该方案从机制上明确数字人民币将实现 M0 向 M1 的跨越，同时坚 持"全局一本账"的双层运营架构，未来或有望实现全国统一的管理服务体 系，对银行业和金融科技领域均产生影响。 【医药生物】和誉-B（2256.HK）近况更新：匹 ...

Core Insights - The article discusses the approval of the high-selectivity small molecule inhibitor, Pimitinib, by the National Medical Products Administration (NMPA) in China for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients [2] - Pimitinib is notable for being developed through a global synchronized clinical trial approach, marking a significant achievement for domestic pharmaceutical companies in China [2] Group 1: Product Development and Approval - Pimitinib is the first innovative drug in China to conduct multi-center Phase III clinical trials simultaneously in the US, Europe, and China, using the same data for the New Drug Application (NDA) [2] - The development of Pimitinib took 9 years and 7 months, significantly shorter than the global average of 15 years for innovative drugs [2] - The drug addresses a clear unmet clinical need for patients with TGCT, a rare disease with an incidence rate of approximately 44 per million in China [2] Group 2: Commercialization and Financial Aspects - The company signed a licensing agreement with Merck in December 2023, granting Merck commercialization rights for Pimitinib in mainland China, Hong Kong, Macau, and Taiwan, along with exclusive global commercialization rights [3] - The company received an upfront payment of $155 million and is set to receive over $400 million in milestone payments and ongoing sales royalties, providing substantial funding for future research and development [3] - Pimitinib has also received breakthrough therapy designation from the FDA and priority medicine designation from the EMA, with application processes in both regions progressing smoothly [3] Group 3: Future Development Pipeline - The company has established a research pipeline with over 20 projects, including a core liver cancer inhibitor, Ipagotene, which has entered critical registration clinical stages [3] - The company is also expanding its focus into areas such as autoimmune diseases, cardiovascular conditions, and diabetes [3]

机构：申万宏源研究 研究员：张静含/陈田甜 多项管线稳步推进中。近期公司公告了多项在研管线进展：①公司口服小分子KRAS G12D抑制剂 ABSK141 的IND 申请获中国药监局批准，该产品在临床前研究中展示出潜在的同类最佳口服生物利用 度；②FGFR2/3 抑制剂ABSK061 治疗儿童软骨发育不全II 期临床试验完成首例患者给药，该产品是全 球范围内第一款进入临床的FGFR2/3 选择性抑制剂，有望在临床上取得更好的安全窗及疗效。 事件：12 月22 日，公司公告，CSF-1R 抑制剂匹米替尼获中国药监局批准上市，用于手术切除可能会 导致功能受限或出现较严重并发症的症状性腱鞘巨细胞瘤（TGCT）成年患者。 首款自研新药匹米替尼上市，后续将由默克推动商业化进程。匹米替尼（商品名：贝捷迈）是公司独立 研发的口服、高选择性且高效的小分子CSF-1R 抑制剂，此前全球III 期MANEUVER 研究结果中，匹米 替尼展示出了同类最佳的ORR，同时安全性优势明显。在2025 年ESMO（欧洲肿瘤内科学会）上公布 的长期随访数据显示，中位随访14.3 个月时，自研究开始即接受匹米替尼治疗的患者，ORR 从25 周的 ...

申万宏源发布研报称，12月22日，和誉-B(02256)公告，CSF-1R抑制剂匹米替尼获中国药监局批准上 市，用于手术切除可能会导致功能受限或出现较严重并发症的症状性腱鞘巨细胞瘤（TGCT）成年患 者。首款自研新药获批上市，开启商业化新征程，同时在研管线稳步推进，实现"自我造血"的良性循 环，维持"买入"评级。 多项管线稳步推进中。近期公司公告了多项在研管线进展：①公司口服小分子KRAS G12D抑制剂 ABSK141的IND申请获中国药监局批准，该产品在临床前研究中展示出潜在的同类最佳口服生物利用 度；②FGFR2/3抑制剂ABSK061治疗儿童软骨发育不全II期临床试验完成首例患者给药，该产品是全球 范围内第一款进入临床的FGFR2/3选择性抑制剂，有望在临床上取得更好的安全窗及疗效。 申万宏源主要观点如下： 盈利预测：该行维持此前盈利预测，预计2025-2027年归母净利润分别为0.63亿1.51亿、1.33亿，对应PE 为131X/55X/62X。 首款自研新药匹米替尼上市，后续将由默克推动商业化进程 匹米替尼（商品名：贝捷迈是公司独立研发的口服、高选择性且高效的小分子CSF-1R抑制剂，此前全 球 ...

申万宏源发布研报称，12月22日，和誉-B(02256)公告，CSF-1R抑制剂匹米替尼获中国药监局批准上 市，用于手术切除可能会导致功能受限或出现较严重并发症的症状性腱鞘巨细胞瘤(TGCT)成年患者。 首款自研新药获批上市，开启商业化新征程，同时在研管线稳步推进，实现"自我造血"的良性循环，维 持"买入"评级。 12月8日，在2025年ESMOAsia大会(欧洲肿瘤内科学会亚洲年会)上公布了ABSK043联合伏美替尼治疗 EGFR突变且PD-L1阳性的经治晚期非小细胞肺癌的II期数据，显示出良好的安全性和耐受性，基于该结 果，中国药监局同意开展该方案的一线治疗研究。此前研究表明，在EGFR突变合并PD-L1高表达中， PD-1/PD-L1单抗与EGFR-TKI的联合方案因严重毒副反应而受到限制。公司的小分子联合方案展示出初 步积极性结果，有望改变该人群的治疗困境。 多项管线稳步推进中。近期公司公告了多项在研管线进展：①公司口服小分子KRAS G12D抑制剂 ABSK141的IND申请获中国药监局批准，该产品在临床前研究中展示出潜在的同类最佳口服生物利用 度；②FGFR2/3抑制剂ABSK061治疗儿童软骨发 ...

Investment Rating - The report maintains a "Buy" rating for the company [2][6]. Core Insights - The approval of the CSF-1R inhibitor, Pimitinib, by the Chinese regulatory authority marks the beginning of a new commercialization journey for the company. This drug is the first self-developed new drug and will be commercialized by Merck [6]. - Pimitinib has shown best-in-class overall response rates (ORR) in clinical trials, with a significant increase from 54% to 76.2% in ORR during a median follow-up of 14.3 months [6]. - The company has multiple ongoing pipeline projects, including the approval of IND for the oral KRAS G12D inhibitor and the completion of the first patient dosing in a clinical trial for the FGFR2/3 inhibitor [6]. Financial Data and Profit Forecast - Revenue projections for the company are as follows: - 2023: 19 million - 2024: 504 million - 2025E: 612 million - 2026E: 756 million - 2027E: 627 million - The net profit attributable to ordinary shareholders is expected to be: - 2023: -432 million - 2024: 28 million - 2025E: 63 million - 2026E: 151 million - 2027E: 133 million - The projected earnings per share (EPS) are: - 2023: -0.67 - 2024: 0.04 - 2025E: 0.09 - 2026E: 0.22 - 2027E: 0.20 [3][7].

转自：智通财经 智通财经12月24日讯（编辑 童古）以下为各家机构对港股的最新评级和目标价： 华创证券就吉利汽车(00175.HK)发布研报称，极氪私有化完成显著增厚利润并强化品牌协同，多款六座 旗舰新车密集交付，销量与ASP双升驱动盈利上行，当前估值显著低于历史中枢，具备较强修复弹性。 长江证券：维持爱康医疗买入评级 招商证券(香港)：将巨子生物评级降至中性 招商证券(香港)就巨子生物(02367.HK)发布研报称，公司正面临声誉危机与核心品牌可复美双11销售下 滑等挑战，2026年或进入战略调整期，缺乏明显反弹催化剂；品牌力修复与客户基础稳固仍存不确定 性，投资逻辑已由增长转向重塑。 中金公司：维持和誉-B跑赢行业评级 目标价20港元 中金公司就和誉-B(02256.HK)发布研报称，公司首个自研创新药匹米替尼获批上市，临床数据优异， ORR达54%（安慰剂3.2%），长期随访ORR提升至76.2%，具备同类最佳潜力；商业化落地将为公司带 来新增长动能。 中金公司：维持蜜雪集团跑赢行业评级 目标价555港元 中金公司就蜜雪集团(02097.HK)发布研报称，公司主品牌在外卖补贴退坡下仍具稳健增长韧性，幸运 ...

中金发布研报称，维持和誉-B(02256)2025年/2026年归母净利润预测0.48亿元/3.20亿元不变。根据DCF 模型，该行维持跑赢行业评级和目标价20港币不变，较当前股价有48.8%的上行空间。2026年建议关 注：匹米替尼美国上市进展、依帕戈替尼2L注册临床进展和1L临床计划、ABSK061、ABSK043的潜在 数据读出机会、早期分子包括ABSK131、ABSK141的开发进展等。 中金主要观点如下： 2025年6月，公司公告匹米替尼在中国的上市申请获得受理，到如今获批仅用了6个多月。此次获批基于 匹米替尼全球III期注册临床MANEUVER研究的第一部分结果，25周ORR54%vs安慰剂3.2%，患者关节 活动度、疼痛等指标也有显著改善，该行认为具备同类最佳潜力。此外，11月公司发表的MANEUVER 长期随访结果进一步表明，中位随访14.3个月ORR提升至76.2%，体现长期用药获益。该行期待匹米替 尼商业化为公司带来新的动能。 其它管线进展 1)12月16日，公司公告FGFR2/3抑制剂ABSK061治疗软骨发育不全(ACH)的II期临床完成首例患者给 药。2)12月8日，公司公告在ESM ...

今年以来，在港股创新药牛市的推动下，恒生医疗保健指数(800804)从年初开盘的2331.02点一路拉升至9月的年内最高点4726.41点，区间累涨幅度达到 102.76%。随后在技术面驱动以及外部多重因素影响下，指数开启一轮向下震荡的行情，截至12月22日，已较前期高点下跌19.06%。 期间，不少前期股价涨幅出众，且拥有硬核创新实力、基本面稳健的公司标的同样受到一定波及，和誉-B(02256)便是其中之一。 智通财经APP观察到，在今年的港股创新药牛市中，和誉作为港股创新药板块内股价拉升的第一梯队，年内股价最大涨幅高达370.95%。虽然公司股价受板 块阶段性震荡下行影响出现一定回落，但随着核心品种匹米替尼(Pimicotinib)在国内顺利获批上市，和誉近期迎来重磅价值催化剂。 重磅"十亿美元分子"顺利商业化 12月22日，和誉发布一则重磅公告：基于全球III期MANEUVER研究的积极数据，中国国家药品监督管理局(NMPA)批准了贝捷迈(盐酸匹米替尼胶囊)的全球 首个新药上市申请。 智通财经APP了解到，贝捷迈是和誉自主研发的的1类新药，也是中国首个自主研发的腱鞘巨细胞瘤(TGCT)系统性治疗药物。作 ...