| 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02256 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 和譽開曼有限责任公司 呈交日期: 2026年1月6日 I. 法定/註冊股本變動 本月底法定/註冊股本總 ...

Core Insights - The report from China Merchants Securities International indicates that the pharmaceutical industry will experience differentiated growth by 2026, with chronic diseases remaining the largest driver for the future of the pharmaceutical sector [1] - The report emphasizes that upgrades on the supply side and improvements in the operational quality of representative companies are key strategies for bottom-up stock selection [1] - It highlights that the US and China will engage in more competition and collaboration in the innovative drug sector, with policy disruptions causing fluctuations but not altering the long-term development direction of the industry [1] Industry Focus - The report expresses a positive outlook on the biopharmaceutical sector, identifying key companies such as Novartis, Innovent Biologics, Aileron Therapeutics, Hansoh Pharmaceutical, and CanSino Biologics as industry favorites [1] - Additional recommendations include companies like Healer, China Resources Pharmaceutical, Thermo Fisher Scientific, and Eli Lilly [1]

Investment Rating - The industry investment rating is "Outperform the Market," indicating an expected performance that exceeds the market by more than 5% over the next six months [29]. Core Insights - The report highlights that the national government will continue to support the renewal of medical equipment in 2026, which is expected to drive demand in the medical device sector. The focus is on high-end equipment and companies with significant performance improvements and international expansion, such as Mindray Medical, United Imaging, Aohua Endoscopy, and Kaili Medical [3]. - The report emphasizes the optimization of application conditions and review processes for equipment renewal projects, aiming to lower investment thresholds and enhance support for small and medium-sized enterprises [3]. - The ongoing policy for equipment renewal is anticipated to sustain a favorable bidding environment for medical devices, with a gradual improvement in performance as inventory clears [3]. Summary by Sections Industry Overview - The report discusses the government's announcement on December 30, 2025, regarding large-scale equipment renewal and the inclusion of various sectors, including healthcare, in the support framework for 2026 [3]. - It outlines the measures to improve the application process for equipment renewal, including stricter requirements for equipment depreciation and minimum usage periods [3]. Investment Opportunities - The report suggests focusing on companies that are expected to show significant performance improvements and have a leading international presence in the medical device sector [3]. - Specific companies recommended for investment include Mindray Medical, United Imaging, Aohua Endoscopy, and Kaili Medical, which are well-positioned to benefit from the anticipated demand for high-end medical equipment [3]. Market Performance - The medical sector has experienced a decline, with a reported drop of 2.06% in the last week, ranking 25th among 28 industries [8][18]. - The report notes that the medical device market is under pressure in the short term due to policy impacts, but improvements are expected as companies innovate and expand internationally [5].

Group 1 - The core viewpoint of the articles highlights the recent approvals of innovative drugs by HeYu Pharmaceutical, including the first systemic treatment for tenosynovial giant cell tumor (TGCT) in China and a KRAS G12D inhibitor for clinical trials [1][2] Group 2 - HeYu Pharmaceutical's CSF-1R inhibitor, Beijiemai (pimitinib hydrochloride capsules), has received approval from the National Medical Products Administration (NMPA), marking it as the first systemic treatment for TGCT in China [1] - The KRAS G12D inhibitor, ABSK141, has also received NMPA approval for an open-label Phase I/II clinical trial to evaluate its safety, tolerability, efficacy, and pharmacokinetics in patients with advanced solid tumors carrying the KRAS G12D mutation [1] - Preliminary data from the Phase II clinical study of the oral PD-L1 inhibitor ABSK043 in combination with the EGFR inhibitor Furmonertinib for non-small cell lung cancer (NSCLC) shows good safety and tolerability, with no observed dose-limiting toxicities or interstitial lung disease [2] - Revenue forecasts for HeYu Pharmaceutical are projected at 612.1 million, 678.8 million, and 627.2 million yuan for 2025-2027, reflecting year-on-year growth rates of 21.5%, 10.9%, and -7.6% respectively, with the current stock price corresponding to price-to-sales ratios of 13.0, 11.7, and 12.7 [2]

Investment Rating - The report maintains a "Buy" rating for the company, indicating a strong expectation for future returns exceeding the market benchmark by over 20% within the next 6-12 months [5][10]. Core Insights - The approval of the CSF-1R inhibitor, Beijiemai® (pimitinib), by the NMPA marks a significant milestone as it is the first systemic treatment for tenosynovial giant cell tumor (TGCT) in China and the first independently developed drug in this category [1][5]. - The clinical trial application for the KRAS G12D inhibitor, ABSK141, has also been approved, with an open-label I/II phase study aimed at evaluating its safety and efficacy in patients with advanced solid tumors carrying the KRAS G12D mutation [1]. - Preliminary data from the Phase II clinical study of the oral PD-L1 inhibitor, ABSK043, in combination with the EGFR inhibitor, furmonertinib, for treating non-small cell lung cancer (NSCLC) shows good safety and tolerability [2]. Financial Projections - Revenue forecasts for the company are as follows: 2025 revenue is projected at 612.1 million, 2026 at 678.8 million, and 2027 at 627.2 million, reflecting growth rates of 21.5%, 10.9%, and -7.6% respectively [4][9]. - The net profit attributable to the parent company is expected to reach 82.2 million in 2025, 133.8 million in 2026, and 98.4 million in 2027, with significant growth rates of 190.5% and 62.7% for 2025 and 2026 respectively [4][9]. - The earnings per share (EPS) is projected to be 0.12 in 2025, 0.20 in 2026, and 0.14 in 2027, indicating a positive trend in profitability [4][9].

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]

Group 1 - The core point of the article is the approval of the CSF-1R inhibitor, Pimitinib, by the Chinese drug regulatory authority for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients, marking the company's first self-developed drug to be approved for commercialization [1] - Pimitinib, marketed as Beijiemai, is an oral, highly selective, and effective small molecule CSF-1R inhibitor, which demonstrated the best overall response rate (ORR) in the global Phase III MANEUVER study, with significant safety advantages [1] - Long-term follow-up data presented at the 2025 ESMO showed that the ORR for patients treated with Pimitinib increased from 54% at 25 weeks to 76.2% at a median follow-up of 14.3 months, with four cases achieving complete remission [1] Group 2 - The company has established a commercial partnership with Merck, which will drive the commercialization process of Pimitinib following its approval [1] - The company is also advancing multiple pipeline projects, including the approval of the IND application for the oral small molecule KRAS G12D inhibitor, ABSK141, and the completion of the first patient dosing in the Phase II trial of the FGFR2/3 inhibitor, ABSK061, which is the first selective FGFR2/3 inhibitor to enter clinical trials globally [2] - The company maintains a "buy" rating and forecasts net profits of 63 million, 151 million, and 133 million for the years 2025-2027, corresponding to PE ratios of 131X, 55X, and 62X, respectively, indicating a positive outlook on the commercial journey and pipeline progress [3]

Core Viewpoint - The approval of the CSF-1R inhibitor, Pimitinib, marks a significant milestone for the company as its first self-developed drug, initiating a new phase of commercialization and maintaining a "buy" rating [1] Group 1: Pimitinib Approval and Commercialization - Pimitinib, an oral, highly selective, and effective small molecule CSF-1R inhibitor, has been approved by the China National Medical Products Administration for the treatment of symptomatic tenosynovial giant cell tumors (TGCT) in adult patients [1] - The drug demonstrated a best-in-class overall response rate (ORR) of 76.2% at a median follow-up of 14.3 months, with four patients achieving complete remission [1] - Merck will drive the commercialization process for Pimitinib following its approval, leveraging its strong global commercialization capabilities [1] Group 2: Ongoing Pipeline Developments - The company has announced positive preliminary data for the oral small molecule PD-L1 inhibitor combined with Vomeletinib for treating EGFR-mutant, PD-L1 positive advanced non-small cell lung cancer, showing good safety and tolerability [2] - The IND application for the oral small molecule KRAS G12D inhibitor, ABSK141, has been approved by the China National Medical Products Administration, indicating potential best-in-class oral bioavailability [2] - The FGFR2/3 inhibitor, ABSK061, has completed the first patient dosing in a Phase II clinical trial for treating children with achondroplasia, being the first selective FGFR2/3 inhibitor to enter clinical trials globally [2] Group 3: Profit Forecast - The company maintains its previous profit forecast, expecting net profits attributable to the parent company to be 63 million, 151 million, and 133 million for the years 2025-2027, corresponding to price-to-earnings ratios of 131X, 55X, and 62X respectively [3]

Core Viewpoint - The approval of the CSF-1R inhibitor, Pimitinib, marks the company's first self-developed drug to be commercialized, initiating a new phase in its business journey while maintaining a steady advancement in its pipeline, leading to a positive self-sustaining cycle [1][2]. Group 1: Product Development and Commercialization - Pimitinib (brand name: Beijiemai) is an orally administered, highly selective, and effective small molecule CSF-1R inhibitor, which has shown the best overall response rate (ORR) in its class during the global Phase III MANEUVER study [2]. - The long-term follow-up data presented at the 2025 ESMO showed that the ORR for patients treated with Pimitinib increased significantly from 54% at 25 weeks to 76.2% at a median follow-up of 14.3 months, with four cases achieving complete remission [2]. - The company has established an exclusive commercialization partnership with Merck, which will expedite the commercialization process of Pimitinib [2]. Group 2: Ongoing Research and Development - Preliminary data from the Phase II study of the oral small molecule PD-L1 inhibitor combined with Vomeletinib for EGFR-mutant and PD-L1 positive advanced non-small cell lung cancer showed good safety and tolerability, leading to approval for first-line treatment research by the Chinese regulatory authority [3]. - The company announced several advancements in its pipeline, including the IND approval for the oral small molecule KRAS G12D inhibitor, ABSK141, which demonstrated potential best-in-class oral bioavailability in preclinical studies [3]. - The FGFR2/3 inhibitor, ABSK061, has completed the first patient dosing in a Phase II clinical trial for treating children with achondroplasia, being the first selective FGFR2/3 inhibitor to enter clinical trials globally [3]. Group 3: Financial Forecast - The company maintains its previous profit forecast, expecting net profits attributable to the parent company to be 63 million, 151 million, and 133 million for the years 2025 to 2027, corresponding to price-to-earnings ratios of 131X, 55X, and 62X respectively [4].

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].