The U.S. Food & Drug Administration (FDA) on Tuesday extended review for Ascendis Pharma A/S‘ (NASDAQ:ASND) New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia. • ASND is in positive territory. Check the fundamentals here.Achondroplasia is a genetic disorder causing dwarfism, characterized by short limbs, a normal-sized torso, and a large head.It is the most common form of skeletal dysplasia and results from a mutation in the FGFR3 gene, which impairs cartilage from ...

（文章来源：证券日报） 证券日报网讯 11月28日晚间，海特生物发布公告称，近日，公司参股公司中眸医疗科技（武汉）有限 公司"ZM-02眼用注射液治疗晚期视网膜色素变性的药物管线"的临床试验申请（受理号：IND32046）获 得美国食品药品监督管理局（FDA）批准，同意其进行临床研究。 ...

国际化生物技术公司百奥赛图(688796.SH)今日(11月28日)启动申购，该股于上交所科创板上市，发行价 每股26.68元(人民币，下同)，发行4750万股新A股，占公司总股本10.63%，料净集资约11.44亿元。公司 以创新技术驱动新药研发，依托"源头抗体分子库 + 靶点人源化小鼠库"双核心平台，加速全球合作伙伴 新靶点、新机制与新疗法的研发进程，推动行业从探索式研发迈向更高确定性的成药时代。 百奥赛图成立于2009年，总部位于北京，在中国(江苏海门、上海)、美国(波士顿、旧金山、圣地亚哥) 及德国海德堡等地设有分支机构，全球扩张能力强，具备重构估值逻辑。截至2025年上半年，公司累计 签署约300项抗体合作协议，成为全球抗体药物研发的重要赋能者。此外，截至6月底，公司已累计获得 195项授权专利，提交496项专利申请。这些底层技术、创新产品和知识产权共同构筑起坚实的护城河， 也为其在国际BD谈判中提供了议价优势。 在持续较高且可控研发投入的同时，公司盈利能力不断增强。2025年上半年营收6.21亿元，同比增长 51.5%，净利润4,800万元，已超过去年全年水平，经营现金流全面转正，展现出强劲的自我 ...

Core Viewpoint - The stock of Pagoda Biopharma-B (02565) opened over 7% higher, reflecting positive market sentiment following the announcement of a lock-up extension by cornerstone investor Yizhe Kangrui Pharmaceutical (Hong Kong) Co., Ltd. [1] Group 1: Stock Performance - Pagoda Biopharma-B's stock rose by 7.03%, reaching HKD 70, with a trading volume of HKD 770,000 [1]. Group 2: Lock-up Extension - The cornerstone investor has agreed not to reduce their holdings of relevant H-shares from the end of the original lock-up period until December 31, 2025, indicating confidence in the company's future prospects [1]. Group 3: Product Approval and Market Potential - The National Medical Products Administration has approved the new drug application for the company's core product PB-119, which is expected to drive significant revenue growth from 2026 to 2029 due to its clinical advantages in treating T2DM and weight loss [1]. - The DCF valuation suggests substantial upside potential for the company, with PB-119 demonstrating outstanding safety and long-lasting effects, particularly suitable for elderly diabetes patients, positioning it as a best-in-class option [1].

研究报告 Research Report 25 Nov 2025 石药集团 CSPC Pharmaceutical Group (1093 HK) 9M25 业绩回顾：成药各板块收入环比改善；关注管线对外授权机会 9M25 Results Review: Sales from All Finished Drug Segments Improved Q-Q; Eyes on Out-Licensing Opportunities 评级 优于大市 OUTPERFORM 现价 HK$7.77 目标价 HK$11.34 HTI ESG 3.0-2.5-3.5 E-S-G: 0-5, (Please refer to the Appendix for ESG comments) 市值 HK$89.53bn / US$11.51bn 日交易额 (3 个月均值) US$174.59mn 发行股票数目 11,522mn 自由流通股 (%) 68% 1 年股价最高最低值 HK$11.48-HK$4.34 注：现价 HK$7.77 为 2025 年 11 月 25 日收盘价 资料来源： Factset 1mth 3mth 12m ...

文 | 时代周报 近日，中药老字号企业片仔癀频现新药研发动态，相继发布了1.1类中药创新药温胆片和化学药品1类创 新药PZH2108片的研发进展情况。这家以片仔癀产品为核心的老牌中药企业，也在化药创新药研发领域 取得进展。 据片仔癀公告介绍，PZH2108片IIa期临床试验采用多中心、随机、双盲、安慰剂对照设计，以"治疗期 不良事件及安全性评估异常的发生及严重程度"作为主要终点。该临床试验方案已获得牵头单位河南省 肿瘤医院医学伦理委员会审核同意，并于2025年11月14日完成首例受试者入组。截至公告日11月21日， 该药物项目的研发投入(未经审计)累计约6100万元。 对于同类产品情况，片仔癀公告介绍，根据全球疾病负担研究数据，2021年，癌症患者中约44.5%会经 历不同程度的癌症疼痛，约有797万癌痛患者。根据2016-2021年癌症病例的发展趋势及癌痛患病率，预 计到2033年，癌痛患者数量将会突破1200万人。阿片类药物为目前癌痛的常规治疗药物。经查询药智网 数据库，2024年，中国医院销售端的镇痛阿片碱类药物销售规模达104.78亿元。 11月21日，片仔癀（600436.SH）发布公告称，近日，公 ...

每经记者｜金喆 每经编辑｜魏官红 H 复宏汉霖孰 0.0 ● ● . . . ● ● · ● 12 : . . . . o o : 。 · C . . . . o C :00 l 'el 根据丁香园Insight数据库统计，6月13日到6月18日，国家药品监督管理局药品审评中心共收到6家上市公司提交的9个化学新药、生物制品新药申请。 一周新药申请 本周，恒瑞医药（600276.SH）、信达生物（01801.HK）、石药集团（01093.HK）各申报2个临床申请；亚盛药业-B（06855.HK）、复宏汉霖 （02696.HK）、康方生物-B（09926.HK）各递交1个临床申请。 按申请类别划分，本阶段申报类别全部为抗肿瘤药物。 《掘金创新药》由每日经济新闻联合丁香园Insight数据库共同推出，旨在解读新药研发进展与趋势，剖析产品竞争力与市场前景，洞察医药资本脉络，见证 医药产业高质量发展。 | 药品名称 | 药品类型 | 申请 | CDE 源企业 | 成分治疗 | 成分最高 | | --- | --- | --- | --- | --- | --- | | | | 内容 | | 令流域 | 进度 | | 重 ...

Group 1 - Daikin Heavy Industries' subsidiary signed a contract worth approximately 1.339 billion yuan for an offshore wind farm project in Europe, accounting for 35.41% of the company's audited revenue for 2024 [1] Group 2 - Zhaoyi Innovation announced that several board members and senior management plan to reduce their holdings by a total of 249,000 shares, due to personal financial needs, with the reduction period set from December 15, 2025, to March 14, 2026 [2] Group 3 - Jushi Chemical received a notice from the China Securities Regulatory Commission regarding an investigation for suspected violations of information disclosure laws, while the company's operations continue normally [3][6] Group 4 - Chaozhuo Aerospace announced a stock suspension due to major matters being planned by its controlling shareholders, which may lead to a change in control [4] Group 5 - Heng Rui Medicine received approval for clinical trials of SHR-1139 injection, a biopharmaceutical with no similar products approved for sale domestically or internationally, with a cumulative R&D investment of approximately 100.13 million yuan [5] Group 6 - Huayou Pharmaceutical's HYP-6589 tablet for treating advanced non-small cell lung cancer received a clinical trial application acceptance notice, with no similar products approved for sale [8] Group 7 - Renfu Pharmaceutical's application for the marketing license of Dexamethasone L-amphetamine capsules was accepted, aimed at treating ADHD, with a cumulative R&D investment of approximately 90 million yuan [10] Group 8 - Huibo Group won a bid for a 1.596 billion yuan project for the restoration of an oil field in Iraq [10]

Praxis Precision Medicines (NasdaqGS:PRAX) 2025 Conference November 18, 2025 08:30 AM ET Company ParticipantsMarcio Souza - President and CEOConference Call ParticipantsAndrew Tsai - Senior Biotech AnalystAndrew TsaiAll right, we're going to get started with our next session. I'm Andrew Tsai, Senior Biotech Analyst at Jefferies, and it's my pleasure to have Marzso Souza joining me today, CEO of Praxis. Welcome, Marzio.Marcio SouzaThank you. Thanks, Andrew. Appreciate it.Andrew TsaiMaybe really briefly, beca ...

Core Viewpoint - The company, Yabao Pharmaceutical, is selling 62% of its stake in its loss-making subsidiary, Taiyuan Pharmaceutical, to Shanxi Tongxiang Times Technology, which will result in a significant reduction of the company's financial burden and improve its operational efficiency [1][2][3]. Group 1: Sale of Loss-Making Subsidiary - Taiyuan Pharmaceutical, established in 2003, has been a significant production subsidiary for Yabao Pharmaceutical, but it has not produced any products since August 2024 and has incurred substantial losses [2][4]. - The sale involves transferring 62% of Taiyuan Pharmaceutical's shares for 87.19 million yuan, after which Yabao will retain only a 5% stake, and Taiyuan will no longer be included in Yabao's consolidated financial statements [2][3]. - This transaction is expected to enhance Yabao's profits by approximately 59 million yuan in 2025 [2]. Group 2: Financial Performance and Challenges - Yabao Pharmaceutical's revenue for 2024 was 2.686 billion yuan, a decrease of 7.69% year-on-year, primarily due to declining sales of key products [4]. - In the first three quarters of 2025, Yabao reported revenues of 1.709 billion yuan, down 19.46% year-on-year, and a net profit of 215 million yuan, down 8.44% [4]. - The decline in performance is attributed to the termination of the SY-009 research project and a decrease in sales of core products [4][6]. Group 3: Research and Development Setbacks - SY-009, a drug intended for type 2 diabetes treatment, was under clinical trials but was terminated due to unsatisfactory results, leading to a full impairment of its capitalized development costs amounting to 55.79 million yuan [5][6]. - The decision to halt SY-009's development reflects the company's cautious approach to managing its financial resources amid ongoing performance challenges [6].