春立医疗(01858)涨超21%，三季度扭亏为盈赚7706.19万元，公司积极开拓国际市场业务。 智通财经APP获悉，港股恒生指数跌0.89%，跌232点，报26050点；恒生科技指数跌1.91%。港股早盘成 交1423亿港元。 恒生生物科技指数反弹2.16%。指数成份股中，映恩生物-B（09606）涨10.88%；三生制药（01530）涨 超10%；信达生物涨6.82%；科伦博泰生物-B（06990）涨5.69%。 福森药业(01652)盘中涨近74%，早盘涨59.42%； 恩扎卢胺软胶囊获批上市，二甲双胍恩格列净片拟中 选国家集采。 荣昌生物(09995)涨6.75%，前三季度收入同比增长四成，亏损明显收窄。 中国光大银行(06818)绩后跌5%，前三季度收入利润双降，公允价值变动损益承压。 华昊中天医药-B(02563)一度跌超37%，上市届满一年迎来大额解禁。 狮腾控股(02562)重挫逾24%创新低，拟发行可转债募资约2.6亿港元，投资黄金及相关产品。 中国国航(00753)重挫逾8%，第三季度纯利下滑逾11%，拟定增A股筹资不超200亿元。 次新股滴普科技（01384）继续大涨18.97%，上市后 ...

春立医疗(01858)涨超21%，三季度扭亏为盈赚7706.19万元，公司积极开拓国际市场业务。 港股恒生指数跌0.89%，跌232点，报26050点；恒生科技指数跌1.91%。港股早盘成交1423亿港元。 恒生生物科技指数反弹2.16%。指数成份股中，映恩生物-B(09606)涨10.88%；三生制药(01530)涨超 10%；信达生物涨6.82%；科伦博泰生物-B(06990)涨5.69%。 福森药业(01652)盘中涨近74%，早盘涨59.42%；恩扎卢胺软胶囊获批上市，二甲双胍恩格列净片拟中 选国家集采。 荣昌生物(09995)涨6.75%，前三季度收入同比增长四成，亏损明显收窄。 中国光大银行(06818)绩后跌5%，前三季度收入利润双降，公允价值变动损益承压。 华昊中天医药-B(02563)一度跌超37%，上市届满一年迎来大额解禁。 狮腾控股(02562)重挫逾24%创新低，拟发行可转债募资约2.6亿港元，投资黄金及相关产品。 中国国航（601111）(00753)重挫逾8%，第三季度纯利下滑逾11%，拟定增A股筹资不超200亿元。 次新股滴普科技(01384)继续大涨18.97%，上市后三天股价 ...

每经记者许立波摄 国家医保局表示，本次集采总体实现"稳临床、保质量、反内卷、防围标"预期目标。一是中选产品与医疗 机构需求更加匹配，强化"稳临床"；二是提高投标企业资质门槛，促进"保质量"；三是引导企业理性报 价，旗帜鲜明"反内卷"；四是全链条规范投标行为，坚持"防围标"。 截至目前，国家医保局共开展多批国家组织药品集采，成功采购490种药品。本次集采拟中选结果公示后将 正式发布，预计全国患者于2026年2月用上新一批质优价宜的中选药。 445家企业参与投标 据国家医保局消息，10月27日，第十一批国家组织药品集中带量采购（以下简称第十一批集采）产生中选 结果。此次集采共纳入55种药品，覆盖抗感染、抗过敏、抗肿瘤、降血糖、降血压、降血脂、消炎镇痛等 领域常用药品，全国共4.6万家医药机构参加报量，445家企业的794个产品参与投标，其中272家企业的453 个产品获得拟中选资格。 10月27日早上7时许，《每日经济新闻》记者在位于上海市青浦区的集采现场看到，距离受理申报材料还有 一定的时间，但已有不少企业代表提着资料袋在门口排队等待；同时，场地外围也有不少企业代表一起寒 暄、讨论此次集采的相关话题。 据记者了 ...

（原标题：跨国药企的中国"棋局"：进退间找寻"价值竞争"定位） 21世纪经济报道记者韩利明报道 日前，国家药监局一纸公告，正式注销氯雷他定片等80个药品注册证书。这也意味着这些药品将面临停 止生产、销售等全链条经营活动。值得关注的是，此次注销均属于"依申请注销"情形，即由企业主动发 起申请，本质上是市场主体基于商业考量做出的战略选择。 从主体构成来看，外资药企是此次注销的主要参与者。按注册证数量粗略统计，80个注销品种中超过 55%的产品来自外资药企或中外合资企业，剩余为本土企业产品。 这也是近年来原研药市场调整的缩影。《中国医疗保险》2024年5月文章显示，据不完全统计，已有161 种进口药未在我国完成再注册，其中不乏默克公司的二甲双胍、葛兰素史克（GSK）的阿德福韦酯片等 曾广泛应用于临床的知名原研药。与此同时，也存在原研药退出后重新布局中国市场的现象，形成"退 场与回归"并存的格局。 对于这一市场波动，奇异佳首席市场官刘检向21世纪经济报道记者指出，"原研药退出并非长期撤离， 而是短期战略调整，中国庞大的市场体量对任何外企都具有不可替代的吸引力。" 瑞银证券中国医疗行业研究主管陈晨向21世纪经济报道记者 ...

Core Viewpoint - The recent decision by the National Medical Products Administration to cancel the registration certificates of 80 drugs, including commonly used medications, has led to significant price increases for certain products, such as the compound drug Taining suppository, which is now priced over 900 yuan for a box of six [1][2]. Group 1: Drug Cancellations - The cancellation includes various commonly used drugs, such as loratadine tablets, finasteride tablets, and vitamin B2 tablets, all of which were voluntarily requested by the companies, indicating a strategic business decision rather than a response to safety concerns [2][3]. - The majority of the cancelled drugs are not exclusive products, meaning that other companies holding similar product registrations can continue their production and sales, mitigating potential supply shortages [2][3]. Group 2: Foreign Pharmaceutical Companies - Over 40 of the cancelled drugs are produced by foreign companies, reflecting a strategic adjustment in response to the implementation of national centralized procurement policies that have significantly reduced drug prices [2][3]. - Notable products among the cancellations include loratadine tablets from Fecar Huari, salbutamol inhalation solution from GlaxoSmithKline, and the compound drug Taining suppository from Xi'an Janssen, all of which were once market leaders [2][3]. Group 3: Market Dynamics - The cancellation of these drugs is indicative of a broader trend where foreign pharmaceutical companies are shifting their focus to more competitive innovative drugs due to declining profit margins on original drugs amid increasing competition from generic products [3][4]. - The market for inhalation medications, such as salbutamol, is becoming increasingly competitive as domestic companies improve their product quality and pricing, leading to a loss of market share for original products [4][5]. - The ongoing price control measures for chronic disease medications, including diabetes drugs, are further squeezing the profit margins of original drugs, prompting companies to rationally decide to cancel their product registrations when market returns do not cover operational costs [5].

本次药品注销还有一个特点，就是80个注销药品中，有40多个生产商是外资企业。业内认为，这是 国家集采政策全面推行下，药品价格大幅下降，外资药企为了保住药品高额利润而主动调整销售策略的 一种表现。 10月21日，记者在美团等互联网药品销售平台看到，由西安杨森制药有限公司生产的复方角菜酸酯 栓（商品名：太宁栓）一盒6枚标价已经超过900元。 造成该药品离奇涨价的原因在于，国家药品监督管理局近期发布消息，决定注销氯雷他定片等80个 药品注册证书，这也意味着这些药品后续将在国内停止生产销售。 80个药品停止生产销售 记者注意到，除了复方角菜酸酯栓，此次注销的药品中还包含多款临床常用药，例如，抗过敏药物 氯雷他定片、男性健康药物非那雄胺片、维生素补充药物维生素B2片等。值得注意的是，这80多个药 品注销均为"依申请注销"，即均由企业主动申请注销，很可能是一种商业选择行为，并非被吊销或是存 在危害人体健康等状况。 不过，这些注销药品绝大多数都不是独家产品，相关企业的批文注销也不影响其他持有同通用名批 文产品企业的正常生产销售活动，一定程度上缓解了同类药品断供的现象。 费卡华瑞的氯雷他定片也在注销行列。费卡华瑞是中国和瑞典 ...

10月15日，国家药品监督管理局发布第102号公告，决定注销氯雷他定片等80个药品注册证书。 根据《中华人民共和国药品管理法》相关规定，对疗效不确切、不良反应大或者因其他原因危害人体健康的药品，应当注销药品注 册证书。而这仅仅是冰山一角——据不完全统计，近一年内国家药监局已注销626个药品注册证书，其中89%为企业主动撤销。 在集采常态化、监管趋严、行业整合加速的多重压力下，中国医药行业正进入"大浪淘沙"的关键时期。曾经依靠"批文经济"躺赚的 时代已经终结，低质量仿制药的生存空间被急剧压缩。 这场淘汰赛不仅关乎企业的生死存亡，更将重塑整个行业的竞争格局。从扬子江药业占据氯雷他定市场近60%份额的"赢家通吃"， 到196家医药企业2024年宣布裁员的行业寒冬，一个更加集中、更加规范、更加残酷的新医药时代正在到来。 氯雷他定片的启示：百家争鸣背后的产能过剩困局 此次被注销的药品中，费森尤斯卡比华瑞制药有限公司(费卡华瑞)的氯雷他定片作为"领衔"品种，格外引人关注。这个看似不起眼 的抗过敏药物，恰恰是中国仿制药产能过剩问题的典型缩影。 氯雷他定作为第二代抗组胺药物，用于缓解过敏性鼻炎、荨麻疹等症状，市场需求相对稳定 ...

Core Points - The National Medical Products Administration (NMPA) announced the cancellation of registration certificates for 80 drugs, including well-known imported medications such as Fexofenadine tablets and Salbutamol inhalation solution [2][5] - Over 55% of the canceled drugs are from foreign pharmaceutical companies or joint ventures, while the remainder are from domestic companies [5] - The cancellations cover multiple therapeutic areas, including allergy treatment, respiratory diseases, diabetes, and oncology [5] - All cancellations were initiated by the companies themselves, indicating a commercial decision rather than safety concerns [5] Drug Specifics - Fexofenadine tablets (10mg) are used for allergic rhinitis and are classified as a Class A over-the-counter and Class A medical insurance drug, also part of the fourth batch of national centralized procurement [5] - GlaxoSmithKline's Salbutamol, an important emergency medication for asthma and COPD patients, is also part of the fourth batch of centralized procurement [5] - Other notable drugs in the cancellation list include Pfizer's Doxorubicin injection, Janssen's Tainin suppository, and Sanofi's GLP-1 diabetes drug Liraglutide injection [5] - Boehringer Ingelheim has preemptively canceled the approval for Dapagliflozin tablets, which were set to be included in the upcoming eleventh batch of centralized procurement, thus forfeiting its qualification for the next round of procurement [5] Market Impact - The withdrawal of these imported drugs is expected to have a limited impact on patient medication options, as there are many high-quality generic alternatives available in the domestic market that have passed consistency evaluations [5]

Core Viewpoint - The National Medical Products Administration (NMPA) has announced the cancellation of registration certificates for 80 drugs, including the antihistamine Loratadine tablets (10mg) from Ferring Pharmaceuticals, indicating a shift in the pharmaceutical landscape in China, particularly affecting foreign and joint-venture companies [1][4]. Group 1: Drug Cancellations - The cancellation of the registration certificates for these drugs is categorized as "voluntary cancellation," suggesting a strategic business decision by the companies rather than regulatory enforcement or health concerns [1][4]. - Over 55% of the cancelled products are from foreign companies, highlighting the competitive pressure faced by multinational pharmaceutical firms in the Chinese market [1][4]. - The cancelled Loratadine tablets, known as "Kemi," have been on the market for over 20 years, indicating that the cancellation pertains to older product registrations [4][5]. Group 2: Market Dynamics - The domestic pharmaceutical industry has undergone significant changes due to policies like centralized drug procurement and price negotiations, leading to the rise of local companies and a reevaluation of foreign firms' strategies in China [1][4]. - The presence of multiple manufacturers for Loratadine tablets (35 for 10mg and 16 for 5mg) suggests that the impact of the cancellation on patient access to medication will be minimal [6][8]. - Other notable cancellations include GSK's inhalation solution for Salbutamol and Pfizer's Doxorubicin injection, both of which are significant in their respective therapeutic areas [7][9]. Group 3: Implications for Future Products - The cancellation of the Dapagliflozin and Metformin combination tablets by Boehringer Ingelheim indicates a strategic withdrawal from upcoming centralized procurement rounds, reflecting the competitive nature of the diabetes medication market [8][9]. - The cancellation of high-profile oncology drugs like Doxorubicin and the rare disease treatment Vimizim underscores the importance of commercial viability in determining a drug's market presence [9][14]. - The withdrawal of drugs from the GLP-1 category, such as Liraglutide by Sanofi, suggests a shift in focus towards more competitive products within the diabetes treatment landscape [12][13].

Company and Industry Summary Company Overview - The company is engaged in the pharmaceutical industry, focusing on the development, production, and sales of chronic disease treatment drugs, particularly in the endocrine field, with over 20 years of experience in this area [3][14]. Financial Performance - In Q1, the company reported a revenue growth of 21.59% year-over-year, with net profit increasing by 30% [2]. - For the year 2024, the company expects sales of 868 million, a year-over-year increase of approximately 22.5%, and a net profit of 177 million, up 28% [5]. - The earnings per share for the year is projected at 2.28 yuan [5]. - R&D expenditure for 2023 was 109.56 million, with 38.4 million allocated to innovative drugs and 71.16 million to generic drugs [5]. Product Development and Pipeline - The company has a robust pipeline, including a new drug DYX-116 developed in collaboration with Yaoming Kande, which has garnered significant investor interest [2]. - The R&D team consists of approximately 150 members, with 100 focused on generic drug development and nearly 50 on innovative drug research [3]. - The company is transitioning from a focus solely on generic drugs to a combination of generic and innovative drugs, aiming to mitigate risks associated with market competition and price reductions from national procurement policies [14][16]. Market Position and Strategy - The company has successfully passed consistency evaluations for several products, positioning itself as a leader in the market [8][9]. - The product portfolio includes treatments for diabetes, hypertension, and related complications, with a comprehensive range of offerings in the diabetes treatment category [20]. - The company is actively expanding its market presence by targeting large hospitals, provincial hospitals, and community healthcare facilities [23]. Challenges and Risks - The company acknowledges the competitive landscape, particularly concerning the upcoming 11th round of national procurement, which may impact pricing and market share [24][33]. - There is a focus on maintaining and expanding the sales of existing products while also preparing for the introduction of new products to sustain growth [33]. Future Outlook - The company aims for a 20% growth in sales revenue for 2025, with expectations for continued growth in key products [33]. - Plans for overseas expansion and partnerships with leading companies are in place to enhance product promotion and funding opportunities [26]. Additional Insights - The company is cautious about the risks associated with innovative drug development, emphasizing a balanced approach between generic and innovative drug strategies [14][16]. - The management is committed to ensuring that the generic drug segment remains a strong pillar for cash flow and profitability while exploring innovative avenues for growth [14][16].