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申万宏源:维持和誉-B(02256)“买入”评级 首款自研新药获批上市
智通财经网· 2025-12-29 06:13
申万宏源发布研报称,12月22日,和誉-B(02256)公告,CSF-1R抑制剂匹米替尼获中国药监局批准上 市,用于手术切除可能会导致功能受限或出现较严重并发症的症状性腱鞘巨细胞瘤(TGCT)成年患 者。首款自研新药获批上市,开启商业化新征程,同时在研管线稳步推进,实现"自我造血"的良性循 环,维持"买入"评级。 多项管线稳步推进中。近期公司公告了多项在研管线进展:①公司口服小分子KRAS G12D抑制剂 ABSK141的IND申请获中国药监局批准,该产品在临床前研究中展示出潜在的同类最佳口服生物利用 度;②FGFR2/3抑制剂ABSK061治疗儿童软骨发育不全II期临床试验完成首例患者给药,该产品是全球 范围内第一款进入临床的FGFR2/3选择性抑制剂,有望在临床上取得更好的安全窗及疗效。 申万宏源主要观点如下: 盈利预测:该行维持此前盈利预测,预计2025-2027年归母净利润分别为0.63亿1.51亿、1.33亿,对应PE 为131X/55X/62X。 首款自研新药匹米替尼上市,后续将由默克推动商业化进程 匹米替尼(商品名:贝捷迈是公司独立研发的口服、高选择性且高效的小分子CSF-1R抑制剂,此前全 球 ...
再迎里程碑!百奥赛图H股成功纳入港股通
Group 1 - The successful inclusion of Baiaosaitu in the Hong Kong Stock Connect marks a significant milestone in the company's capital market development, indicating a new stage in capital accessibility, market recognition, and long-term investment value [1][3] - Baiaosaitu is an international biotechnology company driven by innovative technology for new drug development, focusing on "high-quality source molecule acquisition" and "high-certainty in vivo validation" as its core processes, supported by a leading global platform of "full human antibody library + target humanized mouse library" [2] - The inclusion of H-shares in the Hong Kong Stock Connect allows eligible domestic institutional and individual investors to directly invest in Baiaosaitu's H-shares through the Shanghai and Shenzhen Stock Exchanges [3] Group 2 - The H-share inclusion in the Hong Kong Stock Connect represents a systemic breakthrough in the capital market and will create a more efficient synergy with the company's A-share Sci-Tech Innovation Board platform, further supporting the company's ongoing investments in technology platform transformation, global business expansion, and long-term strategic implementation [5] - Baiaosaitu aims to maintain a technology innovation-oriented approach, deepen its global cooperation network, and steadily enhance operational quality and communication with the capital market, while committing to a more open, transparent, and stable posture to reward long-term investors [5] - The company is positioned as a "global source of new drugs," contributing long-term value to the high-quality development of China's biopharmaceutical industry and global innovation [5]
万邦医药(301520.SZ):控制的合伙企业拟认购私募基金份额
Ge Long Hui A P P· 2025-12-22 13:07
格隆汇12月22日丨万邦医药(301520.SZ)公布,为进一步满足安徽万邦医药科技股份有限公司业务布局 及未来发展需要,更好地借助专业机构的专业力量及资源优势,整合各方资源,提高公司的综合竞争 力,由公司控制的合肥群象齐鸣企业管理合伙企业(有限合伙)(简称"合肥群象")于2025年12月22日 与石河子市隆泰股权投资管理企业(有限合伙)等各方签署了《嘉兴隆峰创业投资合伙企业(有限合伙) 合伙协议》及相关文件,合肥群象拟作为有限合伙人以自有资金认缴出资1,000万元,参与认购嘉兴隆 峰创业投资合伙企业(有限合伙)(简称"合伙企业")的基金份额,认缴比例为12.987%。投资方向:新 药研发、医疗器械研发项目等医药相关领域,主要包括优质的新兴医疗企业,包括但不限于新药、创新 药、医疗器械、医疗服务、诊断、生物技术、医药外包研发企业等。 ...
九洲药业(603456.SH)子公司拟参与投资嘉兴隆峰创业投资合伙企业(有限合伙)
智通财经网· 2025-12-22 08:45
智通财经APP讯,九洲药业(603456.SH)发布公告,公司全资子公司宏洲投资拟参与投资嘉兴隆峰创业 投资合伙企业(有限合伙)。合伙企业认缴出资总额为7700万元(包含本次投资),宏洲投资将作为有限合 伙人以自有资金认缴出资额为1000万元,占合伙企业认缴出资总额的12.987%。 合伙企业投资方向:主要投资于新药研发、医疗器械研发项目等医药相关领域,主要包括优质的新兴医 疗企业,包括但不限于新药、创新药、医疗器械、医疗服务、诊断、生物技术、医药外包研发企业等。 ...
九洲药业子公司拟参与投资嘉兴隆峰创业投资合伙企业(有限合伙)
Zhi Tong Cai Jing· 2025-12-22 08:44
九洲药业(603456)(603456.SH)发布公告,公司全资子公司宏洲投资拟参与投资嘉兴隆峰创业投资合 伙企业(有限合伙)。合伙企业认缴出资总额为7700万元(包含本次投资),宏洲投资将作为有限合伙人以 自有资金认缴出资额为1000万元,占合伙企业认缴出资总额的12.987%。 合伙企业投资方向:主要投资于新药研发、医疗器械研发项目等医药相关领域,主要包括优质的新兴医 疗企业,包括但不限于新药、创新药、医疗器械、医疗服务、诊断、生物技术、医药外包研发企业等。 ...
悦康药业:子公司YKYY032注射液获得NMPA和FDA临床试验批准
Mei Ri Jing Ji Xin Wen· 2025-12-19 08:21
每经AI快讯,12月19日,悦康药业(688658.SH)公告称,公司子公司北京悦康科创医药科技股份有限公 司、杭州天龙药业有限公司近日获得NMPA核准签发的关于YKYY032注射液用于治疗高脂蛋白(a)血症 的《药物临床试验批准通知书》。同时,悦康科创获得FDA关于同意YKYY032注射液用于治疗高脂蛋 白(a)血症进行临床试验的函告。YKYY032注射液是一款偶联N-乙酰半乳糖胺(GalNAc)配体的化学合成 双链siRNA药物,通过RNA干扰机制特异性沉默LPA基因转录的mRNA,从源头阻断脂蛋白(a)[Lp(a)]生 成,拟用于高脂蛋白(a)血症治疗。该新药临床试验申请获NMPA及FDA批准是公司新药研发的阶段性成 果,但药品从研制到投产的周期长、环节多、风险高,对公司近期业绩不会产生重大影响。 ...
我国两项新药研究成果在《自然》发表
Ren Min Ri Bao· 2025-12-18 21:47
此次刊发的两项Ⅲ期临床研究成果,分别是玛仕度肽在2型糖尿病患者中的单药治疗研究(DREAMS— 1)和与口服降糖药联合使用的研究(DREAMS—2),前者由南京大学医学院附属鼓楼医院朱大龙教 授团队、山东第一医科大学附属省立医院赵家军教授团队等全国多个临床研究中心团队与信达生物研发 团队联合完成,后者由北京医院郭立新教授团队与中日友好医院张波教授、杨文英教授等全国多个临床 研究中心团队与信达生物研发团队合作完成。 由我国多家研发单位联合完成的两项降糖减重药物Ⅲ期临床研究成果,北京时间18日在线发表于国际科 学顶级学术期刊《自然》(《Nature》)。 (文章来源:人民日报) ...
复星医药子公司签约Clavis Bio 将最多获3.63亿美元付款
12月18日晚间,复星医药(600196)发布公告,公司控股子公司复星医药产业与合作方Clavis Bio签订 《合作及选择权协议》,根据约定,于约定合作期限内,由复星医药产业与Clavis Bio共同选定靶点(基 于Clavis Bio提名)并推进针对获选靶点化合物(即合作项目)的临床前开发。 同时,Clavis Bio会否就合作项目行使选择权,尚存在不确定性;即使Clavis Bio行使选择权,各合作项 目相关开发注册里程碑付款、销售里程碑付款及特许权使用费,仍须以约定的临床、商业化进展、销售 达成情况等作为触发条件。因此,公司基于后期潜在对外许可实际收取的开发注册里程碑付款、销售里 程碑付款及特许权使用费亦存在不确定性。 Clavis Bio将就该等合作项目享有除中国内地、香港、澳门外的全球范围内开发、生产及商业化独家许 可的选择权;无论合作方是否行使上述选择权,复星医药就该等合作项目均享有于中国内地、香港、澳 门独家开发、生产及商业化的权利。 就在通过合作拓展海外市场的同时,复星医药也在通过收购等方式获取新药管线。12月16日,复星医药 发布公告,控股子公司复星医药产业拟出资14.12亿元控股收购绿谷 ...
12月16日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-16 10:31
Group 1 - Action Education plans to repurchase shares worth between 20 million to 25 million yuan at a price not exceeding 45 yuan per share for employee stock ownership plans or equity incentives [1] - Fulin Technology's shareholders plan to reduce their holdings by up to 2% of the company's total shares, amounting to a maximum of 24.44 million shares starting from December 22, 2025 [2] - Huashu shares' shareholders intend to reduce their holdings by up to 1% of the company's total shares, which is a maximum of 35.94 million shares [3] Group 2 - Silan Microelectronics has obtained a filing certificate for its 12-inch high-end analog integrated circuit chip manufacturing production line project, with an investment of 10 billion yuan and a monthly production capacity of 20,000 wafers [4] - Aerospace Information confirms that its main business does not involve commercial aerospace and that its operations are normal without significant changes [5] - Qinglong Pipe Industry signed a supply contract worth 294 million yuan for PCCP and pressure steel pipes, accounting for 10.43% of its 2024 revenue [6] Group 3 - Huaxin Precision plans to invest up to 1 billion yuan of idle funds in low-risk financial products [7] - Hainan Rubber received insurance compensation totaling approximately 26.65 million yuan for rubber income and tree insurance [8] - Lianmei Holdings announced the suspension of its subsidiary Fulin Thermal Power due to economic slowdown and reduced customer demand [9] Group 4 - Ruifeng Bank has been approved to issue up to 2.5 billion yuan in secondary capital bonds to enhance its capital and risk resistance [11] - China Pacific Insurance reported a 9.4% year-on-year increase in premium income for its life insurance subsidiary, totaling 250.32 billion yuan [12] - Sunshine Nuohuo signed an agreement with Peking University to establish a joint laboratory for innovative drug development [13] Group 5 - Century Huatong completed the cancellation of 56.12 million repurchased shares, reducing its total share capital from 7.428 billion to 7.372 billion shares [14] - Yaxin Security received a government subsidy of 3 million yuan [15] - Haili Biology's subsidiary received registration certification for a bone repair material in Indonesia [16] Group 6 - Yian Technology's subsidiary secured a major project for magnesium alloy components worth 430 million yuan, expected to start production by the end of March 2026 [17] - Jiangte Electric plans to contest the proposed cancellation of its lithium-containing mining rights [18] - COFCO Technology announced the resignation of its deputy general manager due to work changes [19] Group 7 - Fangsheng Pharmaceutical passed the GMP compliance inspection for its raw material production lines [21] - Bohai Ferry announced the resignation of two deputy general managers for personal and age-related reasons [22] - ST Fuhua appointed a new general manager [23] Group 8 - Huazhong CNC received project funding of 17.7 million yuan, accounting for 31.97% of its audited net profit for 2024 [24] - Oppein Home used 15 million yuan of idle funds to purchase a large time deposit with a 0.9% annual yield [25] - China General Nuclear Power's Ningde Unit 6 has begun full construction, utilizing Hualong One technology with a capacity of 1210 MW [26] Group 9 - Jiayuan Technology's chairman has had the investigation order lifted, and the company is operating normally [27] - Fulaixin Materials' application for a specific stock issuance has been approved by the Shanghai Stock Exchange [28] - Shuhua Sports plans to invest up to 500 million yuan in a health industry park project [29] Group 10 - Rhine Biology's stock will continue to be suspended due to ongoing control change and asset acquisition plans [30] - Haishi Science received approval for clinical trials for four innovative drugs targeting various diseases [31] - Hangcai Co. plans to repurchase shares worth between 50 million to 100 million yuan at a price not exceeding 80 yuan per share [32] Group 11 - Yinxin Technology received a cash dividend of 18 million yuan from its subsidiary [33] - Tianfulong plans to increase its wholly-owned subsidiary's capital by 580 million yuan [34] - Poly United's subsidiary won a bid for a stripping project worth 1.528 billion yuan [35] Group 12 - Minglida's deputy general manager resigned due to health reasons [36] - ST Guohua appointed a new deputy general manager [37] - China Xidian's subsidiaries won contracts totaling 1.005 billion yuan for Southern Power Grid projects [38]
广式“加速器”四招助力新药研制
Nan Fang Du Shi Bao· 2025-12-15 23:09
生物活性分子与成药性优化全国重点实验室汇聚了150余名固定研究人员。 受访者供图 开栏语 生物医药产业是决定未来竞争力的关键赛道,也是广东省全力打造的万亿级产业集群。然而,从"实验 室"到"临床",从"获批上市"到"广泛可及",创新之路依然充满挑战与堵点。为此,南方都市报启动"广 州生物医药产业深调研",以媒体为桥,以调研为基,深入一线探访产业链关键环节——从上游研发支 撑的华珍猴场,到引领前沿的叶文才教授实验室,再到康方生物、百奥泰、明复乐、麓鹏制药、达博生 物等代表性创新药企。 我们试图描摹一幅真实、立体的产业图景:既有攀登科技高峰的雄心,也直面"进院难"、资本接力、长 周期坚守等现实课题。此次系列调研,不仅是观察与记录,更旨在搭建对话平台、凝聚产业共识、提供 决策参考,发挥媒体智库的公共价值,为推动广州乃至粤港澳大湾区生物医药产业突破瓶颈、行稳致 远,贡献一份深度的思考与助力。 在国家创新药物研发的版图上,广东正成为生物医药产业的前沿热土。这里,一个依托我国深厚的中药 和天然药物底蕴瞄准现代新药前沿的战略科技力量正加速崛起——生物活性分子与成药性优化全国重点 实验室。 作为暨南大学首个全国重点实验室,它 ...