机构：天风证券 研究员：杨松/曹文清 事件 公司的PD-L1 小分子抑制剂ABSK043 联合KRAS G12C 抑制剂戈来雷塞片开展联合用药治疗KRAS G12C 突变的NSCLC 的临床研究申请获CDE 批准。此前，公司已经与艾力斯就联合用药达成了合作协 议。 ABSK043 初步临床数据疗效和安全性平衡，联合疗法瞄准近半NSCLC 市场ABSK043 具有FIC 潜力， 全球暂无PD-（L）1 小分子药物上市。ABSK043 是一款口服PD-L1 抑制剂，可与PD-L1 受体特异性结 合并诱导其从细胞表面内吞，有效地抑制PD-1/PD-L1 的相互作用，解除PD-L1 介导的T 细胞活化抑制 作用。ABSK043 在多个临床前模型中展现出与已获批PD-L1 抗体相当的抗肿瘤功效。PD-（L）1 口服 抑制剂研发的一大障碍就是出现周围神经病变的风险更高（如Incyte 的INCB086550），而ABSK043 在 临床试验中展现出良好的安全性和显著的抗肿瘤活性。在共入组77 例患者的实体瘤I 期临床中，87.0% 的患者出现TEAE，其中29.9%为≥3 级，无周围神经病变。 除NSCLC 以外，ABS ...

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Insights - The company’s PD-L1 small molecule inhibitor ABSK043 has received approval for clinical research to treat KRAS G12C mutated NSCLC in combination with the KRAS G12C inhibitor, adagrasib [1] - ABSK043 shows potential as a first-in-class (FIC) oral PD-L1 inhibitor, with no other oral PD-(L)1 drugs currently available globally [2] - The initial clinical data indicates a balance of efficacy and safety, with 87% of patients experiencing treatment-emergent adverse events (TEAEs) and no peripheral neuropathy observed [2] - ABSK043 is designed specifically for combination therapy, offering advantages such as a short half-life, reduced immunogenicity, and oral administration flexibility [3] - The market potential for ABSK043 is significant, targeting approximately 45%-60% of NSCLC cases, with ongoing clinical trials in various treatment settings [3] Financial Projections - The company is projected to achieve revenues of 630 million, 685 million, and 637 million yuan for the years 2025, 2026, and 2027 respectively [5] - Expected net profits for the same period are 45 million, 70 million, and 102 million yuan [5] - The target price for the stock is set at 22.88 HKD, with the current price at 19.62 HKD [5] Pipeline Developments - The company has several key assets nearing milestones, including: 1. KRAS-G12D inhibitor ABSK141, expected to receive IND approval in the second half of 2025 [4] 2. Pan-KRAS inhibitor ABSK211, anticipated to enter clinical stages in 2026 [4] 3. CSF-1R inhibitor ABSK021, with an NDA submission planned for the second half of 2025 [4] 4. A bispecific antibody-drug conjugate (BsADC) targeting two pan-cancer targets, expected to achieve preclinical candidate status in early 2026 [4]

该行认为，当前估值仅反映其两款后期候选药物pimicotinib及irpagratinib价值，其具高授权潜力的差异 化创新药则尚未被市场充分认可。 ABSK043可与靶向疗法联合使用，且无重大安全性问题，为患者提 供口服治疗方案。其KRAS系列药物，包括ABSK141和ABSK211，已展示良好口服生物利用度和体内疗 效，并将于下半年至明年进入临床阶段。和誉正开发超越肿瘤学的更多候选药物，其中心血管代谢疾病 药P151已进入IND启动阶段。 该行将和誉目标价由17.5港元上调至25港元，维持"买入"评级。 花旗发表报告指，尽管和誉股价今年累升280%，但在该行覆盖的生物科技股中仍属被低估。 ...

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].

智通财经APP获悉，和誉-B(02256)早盘涨超6%，截至发稿，涨4.92%，报17.93港元，成交额3907.14万 港元。 中金发布研报称，ABSK043 是公司具备全球权益的潜力口服小分子PD-L1 抑制剂。该行认为，公司持 续布局的口服+口服联用方案相较注射+口服联用有望具备更好的患者依从性和安全谱，后续临床进展 值得关注。此外，公司被纳入MSCI全球小盘股指数成分股，有望提升公司的全球资金关注度，或对流 动性产生积极影响。 消息面上，和誉近日宣布，在研口服PD-L1 抑制剂ABSK043 和艾力斯的KRAS G12C抑制剂戈来雷塞片 联用治疗KRAS G12C突变的NSCLC的IND申请在中国获得批准，意味着ABSK043 联用戈来雷塞进入二 期临床。此外，近日公司被纳入MSCI全球小盘股指数成分股。 ...

和誉-B(02256)早盘涨超6%，截至发稿，涨4.92%，报17.93港元，成交额3907.14万港元。 消息面上，和誉近日宣布，在研口服PD-L1抑制剂ABSK043和艾力斯的KRAS G12C抑制剂戈来雷塞片 联用治疗KRAS G12C突变的NSCLC的IND申请在中国获得批准，意味着ABSK043联用戈来雷塞进入二 期临床。此外，近日公司被纳入MSCI全球小盘股指数成分股。 中金发布研报称，ABSK043是公司具备全球权益的潜力口服小分子PD-L1抑制剂。该行认为，公司持续 布局的口服+口服联用方案相较注射+口服联用有望具备更好的患者依从性和安全谱，后续临床进展值 得关注。此外，公司被纳入MSCI全球小盘股指数成分股，有望提升公司的全球资金关注度，或对流动 性产生积极影响。 ...

Summary of He Yu Pharmaceutical Conference Call Company Overview - He Yu Pharmaceutical is focused on the commercialization of its drug, Pimitinib, expected in the first half of 2026, which is anticipated to generate sustainable cash flow and has secured an upfront payment from Merck for operational funding [2][7]. Key Products and Market Potential - **Pimitinib**: Expected peak sales could reach $1 billion or more, with a combined peak sales potential of $2-2.5 billion for two indications [4][11]. - **ABSK061 (FGFR23 Inhibitor)**: Targeting ACH, with a market potential of $4-5 billion, competing against BioMarin, which had sales of approximately $500-600 million last year [2][4][5]. - **ABSK043 (Oral PD-L1 Inhibitor)**: Expected to have data by the end of the year in combination with third-generation EGFR, potentially leading to a competitive advantage due to fewer side effects compared to previous antibody treatments [5][11]. - **KRAS G12D and pan-KRAS Products**: Early-stage research shows best-in-class characteristics, indicating significant overall company value and potential for increased value through international collaborations [2][6]. Financial Performance - The company has shown a clear trend towards profitability, with a stable financial condition and strong cash flow [2][7]. - Market capitalization is projected to reach between 40-50 billion yuan upon market entry in 2026, driven by the pipeline of products including FGFR4 and PD-L1 inhibitors [8]. Future Development and Pipeline - Multiple important pipeline advancements are expected in 2025, including NDA submissions for projects 021 and 0,570, and a pivotal Phase III trial for liver cancer treatment [3]. - The FGFR4 inhibitor is anticipated to enter commercialization by late 2027 to 2028, further enhancing the company's product offerings [3]. Strategic Partnerships and Investments - The company has received investments from Allianz and other high-quality foreign investors, indicating recognition of its fundamental value [13]. - Active share buybacks reflect management's confidence in long-term growth and commitment to shareholder interests [13]. Market Dynamics and Competitive Landscape - The PD-L1 small molecule is positioned to address significant market needs in non-small cell lung cancer, with a potential peak sales of $5 billion [9][10]. - The company is also exploring opportunities in large molecules and non-oncology fields, such as ADCs, showcasing a broad development potential [12]. Conclusion - He Yu Pharmaceutical is strategically positioned with a robust pipeline and strong financial backing, indicating significant growth potential and investment opportunities in the biopharmaceutical sector.

Group 1 - The core viewpoint of the article is that HeYu has received IND approval in China for its oral PD-L1 inhibitor ABSK043 and the KRAS G12C inhibitor, which is expected to attract market attention due to its clinical progress [1] - HeYu has been included in the MSCI Global Small Cap Index, which is anticipated to enhance the company's global funding visibility and positively impact its liquidity [1] - The company maintains its profit forecast for the next two years at 48 million and 320 million, respectively, and has raised the target price by 33.3% to HKD 20, while maintaining an "outperforming the industry" rating [1]