Core Insights - The drug Beijiemai® (pimitidine hydrochloride capsules) developed by HeYu Pharmaceutical has received formal acceptance of its New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT) [4] - Beijiemai® has been approved by the National Medical Products Administration (NMPA) in China for adult patients with symptomatic TGCT who may experience functional limitations or serious complications from surgical resection [2][4] - The NDA acceptance is based on positive results from the global multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study, which demonstrated a significant improvement in objective response rate (ORR) for patients treated with Beijiemai® compared to the placebo group [1] Group 1 - TGCT is a rare locally aggressive tumor that occurs in or around joints, leading to swelling, stiffness, and limited mobility, significantly impacting patients' daily activities and quality of life [2] - Beijiemai® is a novel, oral, highly selective, and effective small molecule CSF-1R inhibitor, which is expected to provide an innovative treatment option for TGCT patients globally, addressing unmet clinical needs in this disease area [2] - The drug has also received Breakthrough Therapy Designation (BTD) from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) [2]

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 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 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]