Group 1 - The company is set to achieve its first commercial product with the development of small molecule therapies, focusing on FIC and BIC, and is expanding into non-tumor and macromolecule fields [1] - The company expects to transition from long-term losses to profitability in 2024 through external licensing agreements [1] - Pimitinib, a BIC CSF-1R inhibitor, has submitted an NDA application in China and is expected to launch in 2026, marking the company's first commercial product [1] Group 2 - Pimitinib has shown best-in-class ORR and significant safety advantages in key Phase III trials for TGCT, with the NMPA accepting its application for market approval [1] - The company has established exclusive commercialization cooperation with Merck for Pimitinib in several regions, reflecting confidence in the product's commercial potential [1] - The company is advancing I/II phase clinical trials for ABSK061, a selective FGFR2/3 inhibitor, with the first patient expected to be enrolled by June 2025 [2] Group 3 - The company is developing ABSK043, a PD-L1 small molecule inhibitor, which is currently the fastest progressing oral PD-L1 inhibitor globally, showing good safety and anti-tumor activity [2] - The company has initiated three II phase clinical trials for ABSK043 in combination therapies for various types of NSCLC and gastric cancer [2] - The company has a target price of 21.68 RMB, indicating a potential 41% upside from its market value as of September 17, 2025 [3]

Investment Rating - The report initiates coverage with a "Buy" rating for the company [8][9]. Core Views - The company is a small molecule innovative drug developer on the verge of launching its first commercial product, Pimicotinib, which has shown significant efficacy and safety in clinical trials [6][8]. - The company is expected to transition from long-term losses to profitability in 2024, driven by licensing agreements and product commercialization [6][23]. - The partnership with Merck for Pimicotinib is a key growth driver, with potential milestone payments and sales royalties expected to enhance revenue [23][24]. Financial Data and Profit Forecast - Revenue projections for 2023 to 2027 are as follows: - 2023: 190 million RMB - 2024: 504 million RMB - 2025E: 612 million RMB - 2026E: 756 million RMB - 2027E: 627 million RMB - Net profit forecasts indicate a turnaround from a loss of 432 million RMB in 2023 to a profit of 28 million RMB in 2024, reaching 151 million RMB by 2026 [7][9]. - The expected PE ratios for 2025 to 2027 are 165X, 69X, and 78X respectively [9]. Product Pipeline and Development - The company has established a comprehensive pipeline with 22 candidate drugs, including 12 in clinical stages, focusing on oncology and expanding into non-oncology areas [30][34]. - Pimicotinib, a CSF-1R inhibitor, is positioned to be the first commercial product, with NDA submissions in China and the US expected in 2025 [34][43]. - Other notable candidates include Epagolatinib for liver cancer and ABSK061 for achondroplasia, showcasing the company's diverse therapeutic focus [8][34]. Market Position and Competitive Landscape - The company is recognized for its differentiated product offerings, with Pimicotinib demonstrating superior efficacy compared to existing treatments in clinical trials [40][41]. - The competitive landscape for CSF-1R inhibitors includes several approved drugs, but Pimicotinib's unique profile positions it favorably for market entry [38][37]. Management Team - The management team possesses extensive experience in drug development and international collaboration, enhancing the company's strategic capabilities [21][22].

Investment Rating - The report initiates coverage with a "Buy" rating for the company [2][8]. Core Insights - The company is a small molecule innovative drug developer, poised to launch its first commercial product, Pimicotinib, which has shown promising results in clinical trials and is expected to generate significant revenue starting in 2024 [5][7][19]. - The financial projections indicate a substantial increase in revenue and profitability, with expected revenues of RMB 504 million in 2024 and RMB 612 million in 2025, transitioning from losses to profits [6][24]. - The partnership with Merck for Pimicotinib is a key driver for revenue growth, with potential milestone payments and sales royalties expected to enhance financial stability [24][26]. Financial Data and Earnings Forecast - Revenue projections for 2023 to 2027 are as follows: RMB 19 million in 2023, RMB 504 million in 2024, RMB 612 million in 2025, RMB 756 million in 2026, and RMB 627 million in 2027, with significant year-on-year growth rates [6][8]. - The net profit forecast shows a turnaround from a loss of RMB 432 million in 2023 to a profit of RMB 28 million in 2024, reaching RMB 63 million in 2025 and RMB 151 million in 2026 [6][8]. - The company’s price-to-earnings (PE) ratios are projected to be 369.2 in 2024, 164.9 in 2025, and 69.3 in 2026, indicating a strong growth trajectory [6][8]. Product Pipeline and Development - Pimicotinib, a CSF-1R inhibitor, is set to be the company's first commercial product, with NDA submissions in China and the US expected in 2025 [7][46]. - The company has a robust pipeline with 22 candidate drugs, including FGFR inhibitors and PD-L1 small molecules, indicating a diversified approach to drug development [31][53]. - The clinical data for Pimicotinib in treating TGCT shows a 54% overall response rate (ORR) in pivotal trials, outperforming competitors [43][44]. Market Position and Competitive Landscape - The company is positioned to capitalize on unmet medical needs in oncology, particularly with Pimicotinib addressing TGCT and cGvHD, where current treatment options are limited [42][48]. - The collaboration with Merck enhances the company's market presence and commercial capabilities, providing a competitive edge in the pharmaceutical landscape [24][47]. - The report highlights the differentiation of the company's products, suggesting a strong potential for sustained partnerships and revenue generation [10].

Core Viewpoint - The company is expanding its product portfolio from small molecule innovation in oncology to non-oncology treatments, with significant advancements in drug commercialization and clinical trials [1][2]. Group 1: Product Development - The company has received acceptance for the new drug application (NDA) of Pimicotinib for treating adult tenosynovial giant cell tumors (TGCT) by the National Medical Products Administration (NMPA) in China, with a target date of June 10, 2025 [1]. - Pimicotinib has also been granted breakthrough therapy designation (BTD) by the FDA and priority medicine (PRIME) designation by the EMA, indicating its potential for global commercialization [1]. - The company has initiated the first patient dosing in a registration study for Epaglutide in patients with FGF19 overexpressing hepatocellular carcinoma (HCC), with promising data from ongoing clinical trials [1]. Group 2: Clinical Trials and Collaborations - The company is exploring the combination of ABSK043 (an oral PD-L1 inhibitor) with other therapies for treating KRAS-G12C mutated non-small cell lung cancer (NSCLC) and is conducting a Phase II clinical study for ABSK043 combined with other agents for EGFR mutated NSCLC [2]. - The latest Phase II study results for Epaglutide combined with Atezolizumab showed an overall response rate (ORR) of ≥50% and progression-free survival (PFS) of ≥7 months [1]. Group 3: Financial Projections - Revenue forecasts for the company 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 [2]. - The current stock price corresponds to price-to-sales (PS) ratios of 17, 15, and 17 for the years 2025, 2026, and 2027, respectively, indicating potential investment opportunities as the company approaches product commercialization [2].

Investment Rating - The report assigns a "Buy" rating for the company [3][17]. Core Insights - The company, He Yu-B (2256.HK), is a small molecule innovative drug company focusing on oncology and expanding into non-oncology treatment pipelines. Since its establishment in 2016, it has concentrated on precision oncology and immunotherapy while exploring non-oncology indications [1][6]. - Pimicotinib has initiated its global commercialization process, with its New Drug Application (NDA) for treating adult tenosynovial giant cell tumors (TGCT) accepted by the National Medical Products Administration (NMPA) in China on June 10, 2025. The product has also received breakthrough therapy designation (BTD) from the FDA and priority medicine (PRIME) designation from the EMA [1][40]. - The company has a robust pipeline with 22 candidate drugs, 12 of which are in clinical development, focusing on small molecules for precision oncology and immunotherapy [32]. Financial Projections - Revenue projections for 2025-2027 are estimated at 612.1 million, 678.8 million, and 627.2 million yuan, reflecting year-on-year growth rates of 21.5%, 10.9%, and -7.6% respectively. The current stock price corresponds to price-to-sales (PS) ratios of 17, 15, and 17 for the respective years [3][17]. - The company achieved total revenue of 657.1 million yuan in the first half of 2025, primarily from Merck's licensing income of 612.1 million yuan (85 million USD), with a net profit of 328.5 million yuan [35]. Key Assumptions - The report highlights that the successful commercialization of Pimicotinib and the clinical data readouts for Ipagoatinib are critical catalysts for stock price appreciation. The company expects significant milestone revenues from Merck's licensing agreements and sales shares from Pimicotinib [15][17]. Pipeline Overview - The company has a diverse pipeline, including Pimicotinib for TGCT and Ipagoatinib for FGF19 overexpressing HCC, with promising clinical data indicating high objective response rates (ORR) and progression-free survival (PFS) [2][3][39].

Group 1 - Huali Family plans to invest up to 300 million yuan to acquire 5%-8.09% of Haihe Pharmaceutical's shares, marking a significant move after years of inactivity in external investments [1] - Haihe Pharmaceutical has successfully commercialized three products, including Gumeitini tablets, which received conditional approval from the National Medical Products Administration in March 2023 and was included in the national medical insurance catalog [2] - The company has a strong pipeline with five products in clinical research, including a PI3Kα inhibitor, which has the potential to be the first of its kind for treating ovarian clear cell carcinoma [3] Group 2 - The domestic innovative drug industry is accelerating, with small molecule drugs maintaining an irreplaceable position in clinical treatment due to their oral convenience and controllable production costs [4] - Huali Family's investment in Haihe Pharmaceutical is a strategic move to optimize its business structure amid challenges in the real estate sector, with expectations of Haihe entering a rapid growth phase by 2027 [4] - This investment reflects Huali Family's recognition of Haihe Pharmaceutical's R&D capabilities and commercial prospects, serving as a crucial step for future business transformation [4]

Core Insights - Fosun Pharma has signed a licensing agreement with Expedition Therapeutics for the development, production, and commercialization rights of the small molecule oral DPP-1 inhibitor XH-S004 globally, excluding mainland China and Hong Kong and Macau [1][2] - Fosun Pharma will retain the rights for XH-S004 in mainland China and Hong Kong and Macau [1] - Expedition will pay up to $120 million in non-refundable upfront payments and milestone payments based on development and annual net sales achievements, potentially totaling up to $525 million [1] Company Overview - XH-S004 is a small molecule oral DPP-1 inhibitor developed by Fosun Pharma, which reduces inflammation by inhibiting DPP-1 and its activated neutrophil serine proteases, thereby blocking the vicious cycle of infection and airway structural damage [2] - Currently, XH-S004 is in Phase II clinical trials for the treatment of non-cystic fibrosis bronchiectasis and in Phase Ib clinical trials for chronic obstructive pulmonary disease (COPD) in mainland China [2] - There are no approved small molecule oral inhibitors with the same molecular mechanism globally as of now [2]

Core Viewpoint - The company Yaojie Ankang (Nanjing) Technology Co., Ltd. has officially listed on the Hong Kong Stock Exchange under the stock code 2617.HK, raising approximately HKD 200 million, attracting significant attention from the capital market with cornerstone investors including Jiangbei Pharmaceutical and Kangfang Biotech [1][3]. Company Overview - Yaojie Ankang is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule innovative therapies for oncology, inflammation, and cardiovascular metabolic diseases. The company has established a pipeline of six clinical-stage candidates and one preclinical candidate, with plans for continuous expansion [3]. - The core product, Tinengotinib (TT-00420), is a unique multi-target kinase (MTK) inhibitor currently in registration clinical trials for cholangiocarcinoma (CCA) patients who have experienced disease progression after prior FGFR inhibitor treatment, with trials being conducted in both China and internationally [3]. Investment Background - The Zijin Advanced Manufacturing Fund, which invested in Yaojie Ankang, has witnessed the company's growth and development. The fund, established in 2018 with a scale of RMB 500 million, focuses on advanced manufacturing and related service industries, investing in key sectors such as rail transportation equipment, high-end ships, industrial robots, and high-end medical devices [4]. - The fund aims to explore quality investment opportunities in strategic emerging industries like biomedicine, contributing to industrial upgrading and innovative development [4].

Core Insights - The company focuses on the field of small molecule innovative drugs, particularly in NSCLC, and possesses both second and third generation ALK-TKIs [1] - The company has a diverse pipeline addressing various cancer indications and urgent clinical needs, including multiple early-stage projects that have achieved significant milestones [1] - The commercial value of the second generation ALK-TKI is about to be realized, and the clinical progress of the third generation ALK-TKI is proceeding smoothly [1] Product Development - SY-707, a second generation ALK-TKI, is under review by NMPA with its NDA accepted in October 2024, and the registration inspection has been completed [2] - SY-3505, the fastest progressing third generation ALK-TKI in clinical trials, shows strong inhibitory effects on key resistant mutations of first and second generation ALK-TKIs [2] - SY-5007, a selective RET-TKI, is currently in phase III clinical trials and has demonstrated good efficacy and safety in patients with RET fusion-positive NSCLC [4] Market Landscape - The ALK-TKI market in China is dominated by second generation products, which are expected to account for 67.33% of the market by 2024, while first generation products are gradually being replaced [3] - Lorlatinib, a third generation ALK-TKI, has rapidly increased its market share since its launch in 2022, projected to reach nearly 15% by 2024 [3] - Alectinib continues to lead the market with a 54.82% share in the hospital sector, while the first generation crizotinib holds a 17.81% market share [3] Financial Projections - The company’s total equity value is estimated at 6.614 billion RMB, with projected revenues of 0.59 billion, 1.43 billion, and 2.87 billion RMB for 2025-2027 [5] - The company is expected to incur net losses of -1.84 billion, -1.71 billion, and -1.74 billion RMB for the same period [5] - Given the imminent launch of SY-707 and the promising clinical progress of SY-3505 and SY-5007, the current market valuation is below the estimated equity value, leading to an "accumulate" rating [5]

Investment Rating - The report assigns an "Accumulate" rating to the company, marking its first coverage [3][8]. Core Insights - The company focuses on the NSCLC small molecule innovative drug sector, possessing both second and third generation ALK-TKIs, with significant advancements in its clinical pipeline [3][17]. - The commercial value of the second generation ALK-TKI is about to be realized, while the third generation ALK-TKI is progressing well in clinical trials [4][60]. - The company has multiple early-stage research projects that have achieved significant milestones, ensuring sustainable development [3][18]. Summary by Sections Section 1: Focus on NSCLC Small Molecule Innovative Drugs - The company specializes in the independent research and development of small molecule innovative drugs, with a pipeline that includes various tumor indications and urgent clinical needs [3][17]. - It is the first domestic company to have both second and third generation ALK-TKIs [3][17]. - As of the 2024 report, the company has 22 proprietary research pipelines, all classified as new drugs [17][18]. Section 2: Commercial Value of ALK-TKIs - The second generation ALK-TKI SY-707 is nearing commercialization, with its NDA accepted by NMPA [4][55]. - The third generation ALK-TKI SY-3505 is the fastest progressing domestic option, with ongoing key clinical trials [4][58]. - The ALK-TKI market in China is dominated by second generation products, which are expected to account for 67.33% of the market by 2024 [60]. Section 3: SY-5007 and RET-TKI Development - SY-5007 is a high-selectivity RET-TKI that is currently in phase III clinical trials, showing promising efficacy and safety [6][22]. - It is the only domestic selective RET-TKI that has entered phase III trials globally, providing a significant competitive edge [6][22]. Section 4: Financial Projections - The company is projected to generate revenues of 0.59 billion, 1.43 billion, and 2.87 billion RMB from 2025 to 2027, with net losses expected to decrease slightly over the same period [7][10]. - The total equity value of the company is estimated at 6.614 billion RMB based on DCF modeling [7][8].