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]

中金发表报告指，和誉-B公告称CSF-1R抑制剂匹米替尼(贝捷迈)在中国获批上市，用于不适合手术的腱 鞘巨细胞瘤的治疗，这是公司第一个获批上市的自研创新药物。该行指，匹米替尼获批速度超该行预 期，临床证据确凿。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ORR 54%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。 展望明年，该行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。该行维 持对该股"跑赢行业"评级及目标价20港元。 ...

中金主要观点如下： 公司近况 12月22日，公司公告CSF-1R抑制剂匹米替尼(贝捷迈)在中国获批上市，用于不适合手术的腱鞘巨细胞瘤 (TGCT)的治疗，这是公司第一个获批上市的自研创新药物。 智通财经APP获悉，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。 匹米替尼获批速度超该行预期，临床证据确凿 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ORR 54%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7 ...

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 ...

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。 回顾，贝捷迈®的获批上市历程，该药在今年5月获得中国NMPA批准纳入优先审评后，其用于治疗腱鞘巨细胞瘤(TGCT)的N ...

Core Insights - The company, He Yu Pharmaceutical, is advancing in "source innovation" through strong new drug development, global clinical capabilities, and international collaborations [1][2] - The company has a robust pipeline with 22 drugs in development, over 10 of which are in clinical stages, highlighted during the R&D Day event on October 30 [1][2] R&D Strategy - He Yu emphasizes a dual-driven strategy of "depth + breadth" to enhance its pipeline, focusing on developing differentiated innovative therapies for unmet clinical needs [2][7] - The company has maintained a compound annual growth rate of 54% in R&D investment since its inception, ensuring a strong pipeline of over 10 clinical-stage oncology products [7] Key Products - The core product, Pimicotinib, is the first Chinese-developed CSF-1R inhibitor entering global Phase III clinical trials, with breakthrough therapy designation from multiple regulatory agencies [4][6] - Pimicotinib has shown significant potential in treating TGCT and other indications, with a projected global peak sales exceeding $2 billion [4][5] Clinical Data - Recent data presented at the ESMO Congress 2025 demonstrated Pimicotinib's strong and durable tumor response in TGCT patients, confirming its potential as a best-in-class treatment [5] - The drug is currently under priority review in China and is expected to submit an NDA in the U.S. by the end of the year, with potential approvals in 2026 [6] Pipeline Development - The company is also exploring FGFR and KRAS targets, with the FGFR4 inhibitor, Absk-011, showing promising clinical results in advanced HCC patients [8][9] - Absk-011 has received breakthrough therapy designation and is positioned to become a leading targeted therapy for liver cancer [8][9] Market Potential - Approximately 30% of global HCC patients have FGF19 overexpression, indicating a significant market opportunity for Absk-011 upon approval [9] - The company is advancing multiple promising candidates, including oral small molecule PD-L1 inhibitors and other innovative therapies, enhancing its commercial prospects [9][10] Financial Outlook - He Yu holds over 2 billion yuan in cash and is recognized for enhancing investor returns through stock buybacks while being in the early stages of commercialization [10] - Recent analyst reports have issued "buy" ratings for the company, with target prices indicating substantial upside potential [10]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leader in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a II phase study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotin for advanced hepatocellular carcinoma (HCC) has commenced, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a II phase study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Group 1 - The core viewpoint is that He Yu-B (02256) is a leading player in small molecule innovative drugs, with projected revenues of RMB 650 million, 680 million, and 730 million for 2025-2027, and net profits of RMB 97 million, 111 million, and 142 million respectively, leading to a target price of HKD 22.06, indicating a potential upside of 48.5% from the current price [1] Group 2 - Global BIC product Pimiatin has shown excellent data at ESMO, with an overall response rate (ORR) of 76.2% in the III phase MANEUVER study for patients with giant cell tumor of the tendon sheath, and a significant improvement in joint activity by 23.9% compared to baseline [2] - The NDA for Pimiatin has been submitted domestically, and the FDA NDA submission is progressing, expected to be submitted in Q4 2025 [2] - Pimiatin is also advancing in a Phase II study for treating chronic graft-versus-host disease [2] Group 3 - The development of innovative drugs is accelerating, with the oral PD-L1 inhibitor ABSK043 and the KRASG12C inhibitor from Ailis receiving IND approval for treating KRASG12C mutated non-small cell lung cancer (NSCLC) patients [3] - The single-agent treatment of Ipagotini for advanced hepatocellular carcinoma (HCC) is underway, with the first patient dosed in June 2025, targeting a population with poor prognosis due to FGF19 overexpression [3] - A novel targeted therapy approach for HCC is being developed, with a Phase II study showing an ORR of ≥50% and a progression-free survival (PFS) of ≥7 months when combined with Atezolizumab [3]

Core Viewpoint - He Yu-B (02256) experienced a significant increase of over 8% in early trading, reaching a price of 19.4 HKD, with a trading volume of 58.4651 million HKD. The report from China Merchants Securities International highlights the potential of the drug pitmiritinib, developed by He Yu, as the most effective CSF-1R small molecule globally, which is set to launch in both China and the U.S., promising ongoing sales revenue for the company. The firm anticipates that Merck has high expectations for this molecule, projecting peak sales revenue close to 1.5 billion USD globally. Citigroup previously noted that the company's valuation reflects only the value of its two late-stage candidates, pitmiritinib and ipatacitinib, while the market has yet to fully recognize the high licensing potential of its differentiated innovative drugs [1][1][1]. Group 1 - He Yu-B's stock rose by 8.2%, reaching 19.4 HKD with a trading volume of 58.4651 million HKD [1] - The drug pitmiritinib is expected to launch in both China and the U.S., providing continuous sales revenue for the company [1] - Merck has high expectations for pitmiritinib, with projected peak sales revenue nearing 1.5 billion USD globally [1] Group 2 - Citigroup indicated that the current valuation of He Yu-B only reflects the value of its two late-stage candidates, pitmiritinib and ipatacitinib [1] - The market has not yet fully recognized the high licensing potential of He Yu-B's differentiated innovative drugs [1]