Investment Rating - The report maintains a positive outlook on the pharmaceutical sector, indicating an "Overweight" rating for the industry, suggesting it is expected to outperform the overall market [32]. Core Insights - The report highlights that the Shenwan Pharmaceutical and Biological Index increased by 0.6% this week, while the Shanghai Composite Index rose by 2.9% and the Wind All A (excluding financials and petrochemicals) increased by 3.7% [4][6]. - The pharmaceutical sector's overall valuation stands at 30.4 times earnings, ranking 9th among 31 Shenwan primary industries [4][8]. - Significant collaborations and clinical trial results were reported, including a $11.4 billion global strategic partnership between Innovent Biologics and Takeda Pharmaceutical, which includes a $1.2 billion upfront payment [5][13]. - Key clinical trial results presented at the 2025 ESMO conference showed promising outcomes for several drugs, indicating advancements in treatment efficacy for various cancers [14][18][19]. Market Performance - The report details the performance of various sub-sectors within the pharmaceutical industry, with notable increases in medical devices (+0.2%), medical consumables (+1.7%), and medical research outsourcing (+5.5%), while traditional Chinese medicine and other biological products saw declines [4][8]. - The report also notes that 99 A-share pharmaceutical companies released their Q3 2025 earnings, with a total revenue of 94.15 billion yuan, reflecting a 1.3% year-on-year increase [20][22]. Key Events - The report mentions that Bairui Tianheng has passed the Hong Kong Stock Exchange hearing and is in the process of listing its H-shares [12]. - The report emphasizes the importance of the 2025 ESMO conference, where several companies presented significant clinical data, enhancing their market visibility and potential investment attractiveness [14][17][18]. Company Recommendations - The report recommends focusing on innovative drug sectors and companies with improving performance in medical devices and upstream sectors, including companies like Hengrui Medicine, Changchun High-tech, and Mindray Medical [5][20].

Core Viewpoint - The company announced the long-term efficacy and safety data of pimicotinib in treating TGCT patients, showcasing strong and durable tumor response rates from the global Phase III MANEUVER study presented at the 2025 ESMO meeting [1][3]. Group 1: Study Results - The MANEUVER study demonstrated a significant objective response rate (ORR) of 76.2% based on RECIST v1.1 criteria after a median follow-up of 14.3 months [3]. - The ORR for the pimicotinib treatment group reached 54% at week 25, compared to only 3.2% in the placebo group [2]. - Patients who switched from placebo to pimicotinib in the second part of the study achieved an ORR of 64.5% [3]. Group 2: Drug Profile - Pimicotinib is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor independently developed by the company [2][4]. - The drug has received breakthrough therapy designation (BTD) from both the NMPA in China and the FDA in the United States, as well as priority medicine designation (PRIME) from the EMA [4]. Group 3: Commercialization and Regulatory Status - The drug has been included in priority review by the NMPA for adult TGCT patients requiring systemic treatment [4]. - A commercialization agreement has been reached between the company and Merck, with Merck responsible for global commercialization of pimicotinib [4].

Core Viewpoint - The company announced the long-term efficacy and safety data of pimicotinib in treating patients with tenosynovial giant cell tumor (TGCT) at the 2025 ESMO conference, demonstrating strong and durable tumor response rates and clinical improvements [1][3]. Group 1: Study Results - The global Phase III MANEUVER study showed that the objective response rate (ORR) for pimicotinib reached 76.2% based on RECIST v1.1 criteria after a median follow-up of 14.3 months [3]. - The first part of the MANEUVER study reported an ORR of 54% for the pimicotinib group at week 25, compared to 3.2% for the placebo group [2]. - After switching from placebo to pimicotinib, patients showed an ORR of 64.5% based on RECIST v1.1 and tumor volume score (TVS) assessments [3]. Group 2: Drug Profile and Regulatory Status - Pimicotinib is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor developed independently by the company [2][4]. - The drug has received priority review status from the NMPA for adult patients with TGCT requiring systemic treatment and has been granted breakthrough therapy designation (BTD) [4]. - In December 2023, the company entered into a commercialization agreement with Merck for pimicotinib, which will be responsible for its global commercialization [4].

Core Viewpoint - The company announced the presentation of long-term efficacy and safety data for pimicotinib in treating patients with tenosynovial giant cell tumor (TGCT) at the 2025 ESMO conference, highlighting strong and durable tumor response rates and clinical improvements [1] Group 1: Study Results - The global Phase III MANEUVER study demonstrated strong and durable tumor response rates for pimicotinib, as assessed by the blinded independent review committee (BIRC) using RECIST v1.1 criteria and tumor volume scoring (TVS) [1] - Objective response rate (ORR) confirmed by the study indicates significant efficacy of pimicotinib in TGCT patients [1] Group 2: Clinical Outcomes - Clinical assessments showed meaningful and sustained improvements in joint mobility, stiffness, pain, and physical function among patients treated with pimicotinib [1] - The long-term feasibility of treatment with pimicotinib has been validated through consistent safety profiles compared to previous analyses [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容所產生或因依 賴該等內容而引致的任何損失承擔任何責任。 此為本公司刊發的自願性公告。本集團無法保證ABSK021最終將成功獲批上市。 本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 承董事會命 和譽開曼有限責任公司 徐耀昌博士 主席 上海，2025年10月17日 於本公告日期，本公司董事會包括執行董事徐耀昌博士、喻紅平博士及嵇靖博 士；以及獨立非執行董事孫飄揚博士、孫洪斌先生及徐海音女士。 1 和譽醫藥於2025年ESMO會議展示匹米替尼臨床III期MANEUVER研究長 期療效和安全性數據 Abbisko Cayman Limited 和譽開曼有限責任公司 （於開曼群島註冊成立的有限公司） （股份代號：2256） 自願性公告 和譽醫藥於2025年ESMO會議展示匹米替尼 臨床III期MANEUVER研究長期療效和安全性數據 和譽開曼有限責任公司（「本公司」，連同其附屬公司統稱「本集團」）謹在此隨附新 聞稿，以告知本公司股東及潛在投資者，本公司之附屬 ...

Summary of the Conference Call for He Yu Pharmaceutical Company Overview - He Yu Pharmaceutical focuses on the development of small molecule innovative drugs in the oncology field since its establishment in 2016 [3][5] - The company has two significant business development (BD) collaborations: one with Merck for the CSF-1R inhibitor Pimiatinib and another with Elysium Pharmaceuticals for the development of the EGFR C797S mutation inhibitor [3][4] Financial Performance - Total revenue for the first half of the year reached 657 million RMB, primarily driven by an 85 million USD upfront payment from Merck [2][7] - Net profit attributable to shareholders was 329 million RMB, with R&D expenses amounting to 228 million RMB [2][7] - As of the end of the first half, the company had approximately 2.3 billion RMB in cash and liquid financial assets [2][7] Key Products and Clinical Developments Pimiatinib (CSF-1R Inhibitor) - Pimiatinib has received acceptance for NDA submission for the treatment of Tenosynovial Giant Cell Tumor (TGCT) and plans to submit applications to the FDA and EMA [2][8] - Global Phase III clinical data shows an objective response rate (ORR) of 54% at 25 weeks, outperforming existing therapies, with no cholestatic liver injury reported [2][8] - Expected peak sales for Pimiatinib are estimated at 900 million RMB, with a valuation of approximately 9 billion RMB based on a 10x PE ratio [3][15] Ipatasertib (FGFR4 Inhibitor) - Ipatasertib shows an ORR of 36.8% in patients with FGFR19 overexpression in hepatocellular carcinoma (HCC), significantly higher than existing second-line treatments [2][10] - Initial data from a combination therapy with Atezolizumab shows an ORR of 50% for first-line treatment of liver cancer [2][10] - The company plans to complete patient enrollment by 2025 and submit for market approval by 2027, with peak sales expected at 1.5 billion RMB and a valuation of around 4 billion RMB [3][15] Other Products - The company is developing multiple products, including oral PD-L1 inhibitors and PRMT5 inhibitors, with various stages of clinical trials [6][12][14] - The pipeline includes potential products targeting cardiovascular metabolic diseases and autoimmune diseases [13][14] Strategic Partnerships - Collaboration with Merck has resulted in a total of 155 million USD in upfront payments and potential milestone payments of up to 610 million USD for Pimiatinib [2][3] - Partnership with Elysium Pharmaceuticals for the development of the EGFR C797S mutation inhibitor has a total contract value of 188 million USD [2][4] Management Team - The company is led by experienced professionals, including Dr. Xu Yaochang and Dr. Yue Hongping, who have held leadership positions in major pharmaceutical companies [5] Future Outlook - The company aims to expand its product pipeline and explore non-oncology areas, leveraging its expertise in small molecules and linker technology [13][14] - Key milestones for investors include upcoming approvals and clinical trial results for Pimiatinib, Ipatasertib, and oral PD-1 inhibitors [16]

Core Viewpoint - The company has received approval from CDE for clinical research on its PD-L1 small molecule inhibitor ABSK043 in combination with KRAS G12C inhibitor for treating KRAS G12C mutated NSCLC, indicating significant potential in the market for this combination therapy [1] Group 1: ABSK043 Development - ABSK043 is an oral PD-L1 inhibitor designed for combination therapy, showing a balance of efficacy and safety in preliminary clinical data [1][3] - The drug targets nearly half of the NSCLC market and has first-in-class (FIC) potential, with no other PD-(L)1 small molecule drugs currently available globally [1][3] - In a Phase I clinical trial involving 77 patients, 87.0% experienced treatment-emergent adverse events (TEAEs), with 29.9% being grade 3 or higher, and no peripheral neuropathy reported [1] Group 2: Clinical Efficacy - In a study of 10 lung cancer patients who had not received prior immune checkpoint inhibitor (ICI) treatment, the overall response rate (ORR) was 40%, with 50% of both EGFR and KRAS mutation patients achieving partial response (PR) [2] - Among EGFR mutation patients, those with PD-L1 TPS ≥50% showed progression after at least one line of EGFR TKI treatment [2] Group 3: Market Potential and Future Trials - ABSK043 has significant market potential in KRAS and EGFR NSCLC, which account for approximately 45%-60% of NSCLC cases, covering various treatment scenarios [3] - The company is also conducting a Phase II clinical trial combining ABSK043 with the third-generation EGFR TKI, furmonertinib, with preliminary safety data expected by Q4 2025 [3] - Beyond NSCLC, ABSK043 is involved in Phase I trials for monotherapy in solid tumors and in combination with FGFR2/3 inhibitors in China [3] Group 4: Other Key Assets and Financial Projections - The company is advancing multiple core assets, including the KRAS-G12D inhibitor ABSK141, which is expected to receive IND approval in H2 2025 [4] - The Pan-KRAS inhibitor ABSK211 is anticipated to enter clinical stages by 2026, while the CSF-1R inhibitor ABSK021 is expected to submit an NDA to the FDA in H2 2025 [4] - Financial projections estimate revenues of 630 million, 685 million, and 637 million yuan for 2025-2027, with net profits of 45 million, 70 million, and 102 million yuan respectively [4]

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for He Yu-B (02256), projecting revenue and net profit growth from 2025 to 2027, alongside significant clinical advancements in its drug pipeline [1][2]. Group 1: Financial Projections - The company is expected to achieve revenues of 630 million, 685 million, and 637 million yuan for the years 2025, 2026, and 2027 respectively [1]. - Projected net profits for the same years are 45 million, 70 million, and 102 million yuan [1]. Group 2: Clinical Developments - The clinical research application for the PD-L1 small molecule inhibitor ABSK043 in combination with the KRASG12C inhibitor, Goresiratinib, has been approved by CDE [1]. - The company has established a collaboration agreement with Elysium for the combination therapy [1]. - ABSK141, a KRAS-G12D inhibitor, shows promising oral bioavailability and safety in animal models, with IND approval anticipated in the second half of 2025 [2]. - The Pan-KRAS inhibitor ABSK211 is expected to enter clinical stages in 2026, demonstrating broad inhibitory effects on various KRAS mutations [2]. - The CSF-1R inhibitor ABSK021 (Pimicotinib) plans to submit an NDA to the FDA for TGCT indication in the second half of 2025 [2]. - A bispecific antibody-drug conjugate targeting two pan-cancer targets is projected to achieve preclinical candidate status in early 2026 [2].

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for the company He Yu-B (02256), projecting revenue and net profit growth from 2025 to 2027, alongside significant clinical research advancements in its drug pipeline [1][2]. Financial Projections - Expected operating revenues for 2025, 2026, and 2027 are CNY 630 million, CNY 685 million, and CNY 637 million respectively [1]. - Projected net profits attributable to the parent company are CNY 45 million, CNY 70 million, and CNY 102 million for the same years [1]. Clinical Research Developments - The clinical research application for the PD-L1 small molecule inhibitor ABSK043 in combination with the KRASG12C inhibitor, Goresiratinib, for treating KRASG12C mutated NSCLC has been approved by CDE [1]. - The company has established a collaboration with Elysium for the combination therapy [1]. Milestone Achievements - ABSK141, a KRAS-G12D inhibitor, shows the best oral bioavailability in animal models and is expected to receive IND approval in the second half of 2025 [2]. - ABSK211, a Pan-KRAS inhibitor, demonstrates broad inhibitory effects on various KRAS mutations and is anticipated to enter clinical stages in 2026 [2]. - The CSF-1R inhibitor ABSK021 (Pimicotinib) is expected to submit an NDA to the FDA for TGCT indication in the second half of 2025 [2]. - A bispecific antibody-drug conjugate targeting two pan-cancer targets is projected to achieve preclinical candidate status in early 2026, aiming to reduce side effects in normal tissues [2].

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]