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和誉-B(2256.HK)近况更新:匹米替尼中国上市申请获批 开启全球商业化之路
Ge Long Hui· 2025-12-31 13:42
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]
和誉-B(02256):近况更新:匹米替尼中国上市申请获批,开启全球商业化之路
Western Securities· 2025-12-30 07:32
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].