Market Overview - The A-share pharmaceutical and biotechnology index rose by 0.14%, outperforming the CSI 300 index by 1.47 percentage points and the ChiNext index by 2.06 percentage points, ranking 15th among 31 sub-industries [4] - The Hong Kong Hang Seng Healthcare Index fell by 1.41%, outperforming the Hang Seng Index by 1.65 percentage points [4] R&D Progress - Heng Rui Medicine submitted an NDA for HRS-9531; He Yu Bio's ABSK043 clinical application is under new undertaking [5] - Xianwei's Enogrelide is in Phase III clinical trials; Xiansheng Pharmaceutical's SIM0278 is in Phase II clinical trials; Yingxi Intelligent's ISM-4808 is in Phase I clinical trials [5] Investment Outlook - Continuous attention to AI healthcare-related investment opportunities is advised [6] - The Ministry of Industry and Information Technology, along with eight other ministries, issued the "Implementation Plan for High-Quality Development of Traditional Chinese Medicine Industry (2026-2030)", aiming to establish a collaborative development system for the entire industry chain by 2030 [6] - The plan focuses on enhancing the stable supply of key traditional Chinese medicine raw materials, improving digital and green levels, and optimizing the structure of the traditional Chinese medicine industry, which is expected to benefit the sector through policy dividends [6] Investment Strategy for 2026 - Future investments in the pharmaceutical sector should increasingly focus on the intrinsic clinical value of medicines, addressing clinical needs of patients [7] - Both domestic medical insurance policies and global expansion strategies are placing higher premiums on clinical value [7]

Investment Rating - The report maintains a "Buy" rating for key companies in the pharmaceutical sector, including Innovent Biologics, Efang Biologics, Tianshili, WuXi AppTec, and Mindray Medical [4][28]. Core Insights - The policy-driven upgrade of traditional Chinese medicine (TCM) industry is expected to enhance industry concentration in the medium to long term, benefiting companies with strong quality control and innovative capabilities [2][24]. - The implementation plan for high-quality development of the TCM industry aims to establish a collaborative development system by 2030, focusing on raw material supply, innovation, production quality control, and internationalization [2][23]. - The investment strategy emphasizes the importance of clinical value in the pharmaceutical sector, recommending a focus on innovative drugs and high-end medical devices [3][26]. Summary by Sections Market Review - The A-share pharmaceutical index rose by 0.14%, outperforming the CSI 300 index by 1.47 percentage points [1][16]. - The Hong Kong Hang Seng Medical Health Index fell by 1.41%, but still outperformed the Hang Seng Index by 1.65 percentage points [1][16]. Policy Insights - The Ministry of Industry and Information Technology and other departments issued a plan to enhance the TCM industry, which includes fostering leading enterprises and establishing high-standard raw material production bases [2][24]. - The plan emphasizes digitalization and sustainability, aiming to raise compliance standards and accelerate the exit of smaller companies from the market [2][25]. Company Updates - Recent clinical progress includes the NDA submission for HRS-9531 by Heng Rui Medicine and the initiation of clinical trials for various drugs by other companies [1][31][32]. - Key companies such as Yunnan Baiyao, Baiyunshan, and Taiji Group are highlighted for their strong positions in raw material supply [2][25]. Financial Forecasts - The report provides earnings per share (EPS) forecasts for key companies, with Innovent Biologics projected to have an EPS of 0.49 in 2025 and WuXi AppTec expected to reach an EPS of 5.07 in the same year [4][28]. - The pharmaceutical manufacturing industry reported a revenue decline of 1.2% year-on-year for 2025, with total revenue reaching 2,487 billion yuan [51].

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]

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].

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]

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].

Core Viewpoint - The report from CICC indicates that HeYu-B's CSF-1R inhibitor, Pimitinib (Beijiemai), has been approved for marketing in China for the treatment of inoperable giant cell tumors of the tendon sheath, marking the company's first self-developed innovative drug approval [1] Group 1: Approval Details - Pimitinib's approval speed exceeded expectations, taking just over six months from the acceptance of its application in June 2025 to approval [1] - The approval is based on the results of the global Phase III MANEUVER clinical trial, which showed a 25-week overall response rate (ORR) of 54% compared to 3.2% for the placebo, with significant improvements in joint mobility and pain indicators [1] Group 2: Future Outlook - The report suggests monitoring the progress of Pimitinib's U.S. market entry, the registration clinical progress of Ipagofitinib in the second-line setting, and the first-line clinical plans [1] - Potential data readout opportunities for ABSK061 and ABSK043, as well as the development progress of early molecules including ABSK131 and ABSK141, are also highlighted [1] - The firm maintains an "outperform" rating for the stock with a target price of HKD 20 [1]