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]

Core Viewpoint - Shanghai Heyu Biopharmaceutical Technology Co., Ltd. announced that its self-developed oral and highly selective small molecule CSF-1R inhibitor, Beijiemai (pimitinib hydrochloride capsules), 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 tumors (TGCT) [1][2]. Group 1 - Beijiemai is a novel, oral, highly selective, and efficient small molecule CSF-1R inhibitor developed independently by the company [3]. - The NDA acceptance is based on positive results from the global multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study, which showed a significant improvement in objective response rate (ORR) for TGCT patients treated with Beijiemai compared to the placebo group [2]. - All secondary endpoints related to key clinical outcomes for TGCT patients showed significant and clinically meaningful improvements, including enhanced joint range of motion and physical function, as well as reduced stiffness and pain [2]. Group 2 - TGCT is a rare locally aggressive tumor that occurs in or around joints, leading to swelling, stiffness, and restricted movement, significantly impacting patients' daily activities and quality of life [2]. - Beijiemai has already been approved by the National Medical Products Administration (NMPA) in China for symptomatic TGCT adult patients who may experience functional limitations or severe complications from surgical resection [3]. - The company has reached an agreement with Merck for the global commercialization rights of Beijiemai, which has also received breakthrough therapy designation (BTD) from the FDA and priority medicine (PRIME) designation from the European Medicines Agency (EMA) [3].

Core Viewpoint - The announcement by He Yu-B (02256) regarding the acceptance of the New Drug Application (NDA) for the oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijiemai (ABSK021), by the FDA marks a significant milestone for the treatment of TGCT patients [1][2]. Group 1: Drug Development and Approval - Beijiemai, developed by He Yu Pharmaceutical, has received FDA acceptance for its NDA, based on positive efficacy and safety results from the global Phase III MANEUVER study [1]. - The drug is expected to be commercially available globally through a partnership with Merck [1]. - Beijiemai was previously approved by the NMPA in China in December 2025 for symptomatic TGCT adult patients who may face functional limitations or severe complications from surgical removal [1]. Group 2: Clinical Efficacy and Safety - The Phase III study demonstrated statistically significant improvement in the objective response rate (ORR) for TGCT patients treated with Beijiemai, assessed at week 25 according to RECIST v1.1 standards [1]. - All secondary endpoints related to key clinical outcomes for TGCT patients showed significant and clinically meaningful improvements, including enhanced joint range of motion and physical function, as well as reduced stiffness and pain [2]. - Long-term data from a median follow-up of 14.3 months indicated a continuous increase in ORR for patients who received Beijiemai treatment from the start of the study [3]. Group 3: Market Potential and Clinical Need - TGCT is a rare locally aggressive tumor that can lead to joint swelling, stiffness, and limited mobility, significantly impacting patients' daily activities and quality of life [3]. - If untreated or recurrent, TGCT can cause irreversible damage to bones, joints, and surrounding tissues [3]. - The ongoing regulatory submissions for Beijiemai in major global markets position the drug as a promising daily oral treatment option that is effective and well-tolerated, addressing unmet clinical needs in the TGCT field [3].

Core Viewpoint - The announcement highlights the acceptance of the New Drug Application (NDA) for the novel oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijimai (ABSK021), by the FDA for the treatment of TGCT patients, indicating a significant advancement in addressing an unmet clinical need in this rare tumor type [1][2]. Group 1 - Beijimai is developed by Shanghai Heyu Biopharmaceutical Technology Co., Ltd. and is licensed to Merck for global commercialization [1]. - The NDA acceptance is based on positive efficacy and safety results from the global multi-center, randomized, double-blind, placebo-controlled Phase III MANEUVER study [1]. - The study demonstrated a statistically significant improvement in the objective response rate (ORR) for TGCT patients treated with Beijimai, assessed at week 25 according to RECIST v1.1 criteria [1]. Group 2 - All secondary endpoints related to key clinical outcomes for TGCT patients showed significant and clinically meaningful improvements, including enhanced joint range of motion and physical function, as well as reductions in stiffness and pain [2]. - Long-term data with a median follow-up of 14.3 months indicated a sustained increase in ORR for patients who received Beijimai treatment from the start of the study [2]. - TGCT is a rare locally aggressive tumor that can lead to joint swelling, stiffness, and limited mobility, significantly impacting patients' daily activities and quality of life [2].

Core Viewpoint - The new drug application (NDA) for the oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijiemai® (ABSK021), developed by the subsidiary of He Yu-B (02256.HK), has been officially accepted by the U.S. Food and Drug Administration (FDA) for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT) [1]. Group 1 - The drug Beijiemai® is a novel oral treatment targeting CSF-1R, indicating a significant advancement in the therapeutic options for TGCT patients [1]. - The acceptance of the NDA by the FDA marks a critical milestone for the company and its product development pipeline [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。 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 貝捷邁® NDA獲FDA受理，用於治TGCT 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，本公司之附屬公司上海和譽生物醫 藥科技有限公司（「和譽醫藥」）宣佈，其自主研發的新型、口服、高選擇性且 高效的小分子集落刺激因子1受體(「CSF-1R」)抑制劑貝捷邁® （鹽酸匹米替尼膠 囊，ABSK021）用於腱鞘巨細胞瘤（「TGCT」）患者系統性治療的新藥上市申請 （「NDA」）已獲美國食品藥品監督管理局（「FDA」）正式受理。 此為本公司刊發的自願性公告。本集團無法保證貝捷邁®最終將成功實現商業化。 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 ...

Core Viewpoint - The new drug application (NDA) for the oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijiemai® (pimitinib hydrochloride capsules), developed by He Yu Pharmaceutical, has been officially accepted by the FDA for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT) [1][2] Group 1: Drug Development and Approval - Beijiemai® has been developed by He Yu Pharmaceutical and is licensed to Merck for global commercialization [1] - The drug received approval from the National Medical Products Administration (NMPA) in China in December 2025 for symptomatic TGCT adult patients who may experience functional limitations or severe complications from surgical resection [1] - The NDA acceptance by the FDA is based on positive results from the global multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study [2] Group 2: Clinical Study Results - The study demonstrated that patients with TGCT treated with Beijiemai® showed a significantly higher objective response rate (ORR) at week 25 compared to the placebo group, as assessed by the blinded independent review committee (BIRC) using RECIST v1.1 criteria [2] - All secondary endpoints related to key clinical outcomes for TGCT patients showed significant and clinically meaningful improvements, including enhanced joint range of motion and physical function, as well as reductions in stiffness and pain [2] - Long-term data with a median follow-up of 14.3 months indicated a continuous improvement in ORR for patients who received Beijiemai® treatment from the start of the study [2] Group 3: Disease Context and Market Potential - TGCT is a rare locally aggressive tumor that occurs in or around joints, leading to swelling, stiffness, and restricted movement, significantly impacting patients' daily activities and quality of life [2] - If not treated promptly or if recurrence occurs, TGCT can cause irreversible damage to bones, joints, and surrounding tissues [2] - With the ongoing submissions and future approvals in major global markets, Beijiemai® is expected to provide an innovative treatment option that is effective, well-tolerated, and administered once daily, addressing the unmet clinical needs in this disease area [2]

Core Viewpoint - The new drug application (NDA) for the oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijiemai (Pimicitin Hydrochloride Capsules), developed by He Yu Pharmaceutical, has been officially accepted by the FDA for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT) [1][2] Group 1: Drug Development and Approval - Beijiemai has been developed by He Yu Pharmaceutical and licensed to Merck for global commercialization [1] - The drug received approval from the National Medical Products Administration (NMPA) in China in December 2025 for symptomatic TGCT adult patients who may experience functional limitations or severe complications from surgical removal [1] - The NDA acceptance by the FDA is based on positive results from the global multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study [2] Group 2: Clinical Study Results - The study demonstrated that patients with TGCT treated with Beijiemai showed a significantly higher objective response rate (ORR) compared to the placebo group at week 25, as assessed by the blinded independent review committee (BIRC) using RECIST v1.1 criteria [2] - All secondary endpoints related to key clinical outcomes in TGCT patients showed significant and clinically meaningful improvements, including enhanced joint range of motion and physical function, as well as reductions in stiffness and pain [2] - Long-term data with a median follow-up of 14.3 months indicated a continuous improvement in ORR for patients who started treatment with Beijiemai [2] Group 3: Disease Context and Market Potential - TGCT is a rare locally aggressive tumor occurring in or around joints, leading to swelling, stiffness, and restricted movement, significantly impacting patients' daily activities and quality of life [2] - If untreated or recurrent, TGCT can cause irreversible damage to bones, joints, and surrounding tissues [2] - With the ongoing submissions and future approvals in major global markets, Beijiemai is expected to provide an innovative treatment option that is effective, well-tolerated, and administered once daily, addressing the unmet clinical needs in this disease area [2]

Core Viewpoint - The new drug application (NDA) for the oral, highly selective, and effective small molecule CSF-1R inhibitor, Beijiemai® (pimitinib hydrochloride capsules), developed by He Yu Pharmaceutical, has been officially accepted by the FDA for the systemic treatment of patients with tenosynovial giant cell tumor (TGCT) [1][2] Group 1: Drug Development and Approval - Beijiemai® was developed independently by He Yu Pharmaceutical and is licensed to Merck for global commercialization [1] - The drug received approval from the National Medical Products Administration (NMPA) in China in December 2025 for symptomatic TGCT adult patients who may experience functional limitations or severe complications from surgical resection [1] - The NDA acceptance by the FDA is based on positive results from the global multicenter, randomized, double-blind, placebo-controlled Phase III MANEUVER study [2] Group 2: Clinical Study Results - The study demonstrated that patients with TGCT treated with Beijiemai® showed a significantly higher objective response rate (ORR) compared to the placebo group at week 25, as assessed by a blinded independent review committee (BIRC) using RECIST v1.1 criteria [2] - All secondary endpoints related to key clinical outcomes for TGCT patients showed significant and clinically meaningful improvements, including enhanced joint range of motion and physical function, as well as reductions in stiffness and pain [2] - Long-term data from a median follow-up of 14.3 months indicated a continuous increase in ORR for patients who received Beijiemai® treatment from the start of the study [2] Group 3: Disease Context and Market Potential - TGCT is a rare locally aggressive tumor that occurs in or around joints, leading to swelling, stiffness, and restricted movement, significantly impacting patients' daily activities and quality of life [2] - If untreated or recurrent, TGCT can cause irreversible damage to bones, joints, and surrounding tissues [2] - With the ongoing submissions and future approvals in major global markets, Beijiemai® is expected to provide an innovative treatment option that is effective, well-tolerated, and administered once daily, addressing the unmet clinical needs in this disease area [2]

Group 1 - CSF-1R highly selective small molecule Pimitinib has been approved for the treatment of symptomatic adult patients with tenosynovial giant cell tumor (TGCT) that may lead to functional limitations or serious complications after surgical resection [1] - Pimitinib is the company's first self-developed innovative drug product, demonstrating good efficacy and safety [1] - The MANEUVER III phase study showed an overall response rate (ORR) of 54.0% at 25 weeks for patients treated with Pimitinib, increasing to 76.2% at a median follow-up of 14.3 months [1] Group 2 - Patients who switched to Pimitinib from the control group also experienced clinical benefits, with an ORR of 64.5% at a median follow-up of 8.5 months [2] - Pimitinib has a higher ORR compared to existing drugs like Pexidartinib and Vimseltinib, which have ORRs of 39% and 40% respectively, and Pimitinib does not carry the risk of cholestatic liver toxicity [2] - The global commercialization process for Pimitinib is accelerating, with approvals in China and recognition from the FDA and EMA for breakthrough therapy designation and priority medicine status [2] Group 3 - ABSK043 is designed for combination therapy and is currently undergoing three phase II clinical trials in conjunction with other treatments [3] - The most common driver gene mutation in non-small cell lung cancer (NSCLC) is the EGFR mutation, and third-generation EGFR-TKIs have become the standard first-line treatment [3] - Previous studies indicate that the efficacy of third-generation EGFR-TKIs is inferior in patients with high PD-L1 expression compared to those with low or negative expression [3] Group 4 - In a phase II clinical trial of ABSK043 combined with Vemurafenib, the disease control rate (DCR) reached 71% and the ORR was 25% among patients with EGFR mutations and positive PD-L1 [4] - The company has a robust pipeline with over 10 clinical-stage oncology products, including the Pan-KRAS inhibitor ABSK211 expected to enter clinical stages by 2026 [4] - Revenue forecasts for the company are projected at 630 million, 685 million, and 637 million yuan for 2025-2027, with net profits expected to be 45 million, 70 million, and 102 million yuan respectively [4]