排名前五的靶点	数量

STING(干扰素基因刺激蛋白)	4
HER2(受体蛋白酪氨酸激酶 erbB-2)	3
EP1(前列腺素EP1受体)	2
ALK x ROS1 x c-Met	2
CD40(肿瘤坏死因子受体超家族成员5)	2

关联

266

项与中国生物制药有限公司相关的药物

Garsorasib

格索雷塞

靶点

KRAS G12C

作用机制

KRAS G12C抑制剂

在研机构

益方生物科技（上海）股份有限公司 [+2]

原研机构

益方生物科技（上海）股份有限公司

在研适应症

KRAS G12C突变非小细胞肺癌 [+7]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-11-05

Envonalkib

枸橼酸依奉阿克

靶点

ALK x ROS1 x c-Met

作用机制

ALK抑制剂 [+2]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-06-11

Benmelstobart

贝莫苏拜单抗

靶点

PDL1

作用机制

PDL1抑制剂 [+1]

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

中国

首次获批日期2024-04-30

1,136

项与中国生物制药有限公司相关的临床试验

NCT06943677

/ Not yet recruiting临床1期

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsules in Subjects With Advanced Malignant Tumors

The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3019 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3019 capsules.

开始日期2025-05-01

申办/合作机构

正大天晴药业集团股份有限公司

NCT06900920

/ Not yet recruiting临床3期

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia (ITP)

This is a randomized, double-blind, placebo-controlled Phase III clinical study designed to demonstrate that TQB3473 tablets significantly improve the sustained response rate compared to placebo in adult patients with chronic ITP who have previously received standard corticosteroid therapy and have failed or relapsed after at least one standard ITP treatment.
The study consists of a treatment period and a safety follow-up period.

开始日期2025-05-01

申办/合作机构

正大天晴药业集团股份有限公司

NCT06429397

/ Not yet recruiting临床2期IIT

A Single-arm, Multicenter, Prospective Phase II Clinical Study of Anlotinib Combined With Benmelstobart in the First-line Treatment of Advanced Pheochromocytoma/Paraganglioma

There is currently no standard first-line treatment for stage PPGL, and the 5-year survival rate of patients with advanced pheochromocytoma/paraganglioma (PPGL) is low, ranging from 30% to 60%. At present, several domestic teams have carried out clinical studies on the treatment of advanced PPGL with good efficacy. In the early stage, our center used anrotinib to treat advanced PPGL, and the overall effective rate reached 44%. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat advanced PPGL patients. The effective rate reached 66% (2/3). Therefore, the investigators plan to further conduct prospective studies to explore the efficacy and safety of anlotinib combined with PD-1 monoclonal antibody in the treatment of advanced PPGL, so as to bring benefits to patients with advanced PPGL.

开始日期2025-05-01

申办/合作机构

中山大学

[+1]

100 项与中国生物制药有限公司相关的临床结果

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0 项与中国生物制药有限公司相关的专利（医药）

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445

项与中国生物制药有限公司相关的文献（医药）

2025-12-01·Cancer Chemotherapy and Pharmacology

Food effect trial of the pharmacokinetics and safety of TQ05105 in healthy Chinese subjects

Article

作者: Su, Zhengjie ; Cui, Yingzi ; Wang, Yanli ; Zhou, Yannan ; Cheng, Yang ; Yang, Haimiao ; Deng, Qiaohuan ; Dai, Jun ; Liu, Zhengzhi ; Ren, Qing

PURPOSEThis study aims to investigate the effect of food intake on the pharmacokinetics of TQ05105 tablets in healthy Chinese subjects, and to evaluate the safety in these subjects.METHODSThis Phase I clinical trial involved healthy subjects who received a single oral dose of 15 mg TQ05105, with a 2-day washout period between each period. The plasma concentrations of TQ05105 and its metabolite TQ12550 were quantified using a validated liquid chromatography-tandem mass spectrometry method. Safety assessments were conducted throughout the study.RESULTSThe study enrolled 16 healthy Chinese subjects (10 males and 6 females). Compared with the fasting condition, the postprandial administration of TQ05105 resulted in significant reductions in the maximum concentration (C_max) and area under the curve (AUC) of both TQ05105 and its metabolite TQ12550. Additionally, both the time to peak concentration (T_max) and half-life (t_1/2) of TQ05105 and its metabolite were prolonged under postprandial conditions. No serious adverse events were reported during the study.CONCLUSIONThe findings demonstrate that food intake significantly alters the pharmacokinetic parameters of TQ05105 and its metabolite TQ12550, with a notable decrease in C_max and AUC, and an increase in T_max and t_1/2. The single dose of the drug was well tolerated.REGISTRATION INFORMATIONThis trial had registered at the Clinical Trials.gov on August 08, 2023 ( https://clinicaltrials.gov , NCT05982106).

2025-04-25·Cancer Research

Abstract LB194: Revolutionizing cancer treatment with the first SHP2 PROTAC

作者: Li, Xiaobo ; Li, Wenming ; Zhou, Liying ; Liu, Junrong

AbstractSHP2 is a mediator in tumor-related signaling pathway, a suppressor of PD-1, associated with solid tumors and leukemias. SHP2 is recognized as a driver in myeloid leukemia. Inhibition of SHP2 has potential to reverse progression of myeloid leukemia, rather than eradicating differentiated leukemic cells. However, SHP2's bifunctional roles-encompassing both phosphatase-dependent and -independent activities-pose challenges for therapeutic targeting. SHP2 inhibitors, like JAB3312, is limited to inhibiting phosphatase activity and evaluated in combination regimens rather than as standalone therapies. To address limitations, we developed a PROTACs with a novel, high-affinity as warhead. This strategy enables complete degradation of SHP2, we developed a novel SHP2 degrader TDS0593, exhibited superior preclinical performance. In vitro, TDS0593 achieved dose-dependent SHP2 degradation, with a Dmax of 91.7% and a DC50 of 1.145 nM in MV411 leukemia cells. Mechanistic studies confirmed TRD209 acts via ubiquitin-proteasome pathway, as validated by TAK-243 and MG132 blockade assays. In vivo, TDS0593 demonstrated potent antitumor efficacy. In MV411 xenograft models, at 2.5 mg/kg (QD) achieved >90% TGI, a 5 mg/kg (QD) dose resulted in complete TGI. In order to established mouse model, leukemia HSC from donor mice with CD45.2 cells has been transplanted into CD45.1 mice. In murine models, administration of TDS0593 resulted in a significant reduction in proportion of myeloid cells both in PB and BM. The number of myeloid stem and progenitor cells in the BM approached normal levels. TDS0593 corrects the aberrant differentiation pathway of hematopoietic stem cells to a certain extent, highlighting its potential as an etiological treatment for myeloid leukemia. Notably, TRD209 showed greater potency in solid tumor PDX, with a 0.5 mg/kg (QD) dose achieving >99% TGI. Immunohistochemical analysis confirmed suppression of p-ERK1/2 expression in tumors either. TDS0593 represents a first-in-class SHP2 degrader with potential to overcome the limitations of current inhibitors by targeting both phosphatase-dependent and -independent activities. TDS0593 offer a novel strategy for the treatment of myeloid leukemia by correcting aberrant myeloid-biased differentiation of HSC/HSPC. This innovative approach aims to rectify the underlying dysregulation in hematopoietic differentiation processes, achieving efficacy in myeloid leukemia.Citation Format:Junrong Liu, Liying Zhou, Xiaobo Li, Wenming Li. Revolutionizing cancer treatment with the first SHP2 PROTAC [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr LB194.

2025-04-21·Cancer Research

Abstract 400: Preclinical development of TQB3019: A potent and selective oral BTK degrader leveraging the OAPD® platform to overcome acquired resistance mutations

作者: Zhang, Ying ; Xu, Hongjiang ; Zhao, Wei ; Zhang, Xiquan ; Liu, Jin ; Liu, Baomin ; Xu, Sheng ; Ren, Jing ; Wang, Xiaojin ; Shi, Wei ; Yang, Ling ; Wang, Jinan

AbstractBackground:Bruton's tyrosine kinase (BTK) is a clinically validated target for the treatment of hematological malignancies. Small molecule inhibitors targeting BTK have been used in the clinic to manage B-cell malignancies. However, the emergence of BTK mutations, such as BTK C481S, ect., can lead to drug resistance to both covalent and non-covalent inhibitors. To address the acquired resistance mutation issues, here we report TQB3019, a novel BTK degrader, discovered using Chia Tai Tianqing's proprietary Platform for Orally Available Protein Degrader (OAPD®).Result:TQB3019, a highly potent oral BTK degrader, induced robust BTK degradation with a DC50 of less than 0.1 nM and Dmax of greater than 95% in DLBCL cell line OCI-LY10 at 6 hours. Proteomics studies revealed excellent degradation selectivity, then no Ikaros and Aiolos degradation was further confirmed in OCI-LY10 cells and human T cells. TQB3019 also exhibited efficient degradation kinetics in cells harboring both wild-type and C481S mutation, achieving 80% of BTK degradation within 2 hours at 10 nM. Importantly, TQB3019 induced strong cell proliferation inhibition in cells carrying wild-type BTK (IC50 of sub-nanomolar range) and BTK C481S mutation (IC50 of single-digit nanomolar range). TQB3019 exhibits favorable kinase selectivity of BTK over EGFR, and did not degrade EGFR in lung cancer cell line A431. Unlike covalent inhibitor ibrutinib, TQB3019 also demonstrated improved selectivity for BTK over TEC. TQB3019 using a novel designed CRBN ligand showed over 14-fold higher binding affinity to CRBN protein compared to pomalidomide. Additionally, TQB3019 showed weak inhibition of hERG and cytochrome P450 activities (CYPs) (hERG IC50 >30 μM and CYPs IC50 >10 μM). TQB3019 demonstrated promising metabolic stability in vivo with a mean residence time (MRT) of over 10 hours in dogs, and exhibited good oral bioavailability in both rodents and dogs. Furthermore, oral administration of TQB3019 led to dose-dependent tumor growth inhibition (TGI>95% at 15mg/kg) even complete tumor regression (30mg/kg) in a BTK wild-type TMD8 xenograft tumor model, without significant weight loss.Conclusion:Developed using Chia Tai Tianqing’s OAPD® platform, TQB3019 is an orally available BTK degrader with promising potency, superior selectivity, and favorable pharmacological properties. With IND (Investigational New Drug) application forthcoming, TQB3019 represents a promising therapeutic candidate to address resistance challenges associated with traditional BTK inhibitors.Citation Format:Jing Ren, Jinan Wang, Sheng Xu, Jin Liu, Ying Zhang, Xiaojin Wang, Baomin Liu, Wei Shi, Hongjiang Xu, Ling Yang, Wei Zhao, Xiquan Zhang. Preclinical development of TQB3019: A potent and selective oral BTK degrader leveraging the OAPD® platform to overcome acquired resistance mutations [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 400.

6,835

项与中国生物制药有限公司相关的新闻（医药）

2025-05-05

·信狐药迅

仿制药上市申请12品规收到通知书，来看看哪些品种| 新获批(4.27-5.5）

每周药品注册获批数据，分门别类呈现，一目了然。(4.27-5.5）新药上市申请无新药临床申请药品名称企业注册分类受理号DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500342DZD6008片迪哲(江苏)医药股份有限公司1CXHL2500340TCC1727片北京泰德制药股份有限公司1CXHL2500226TCC1727片北京泰德制药股份有限公司1CXHL2500225X-L177胶囊中国科学院上海药物研究所1CXHL2500217X-L177胶囊中国科学院上海药物研究所1CXHL2500216X-L177胶囊中国科学院上海药物研究所1CXHL2500215TFX06片浙江扬厉医药技术有限公司1CXHL2500212TFX06片浙江扬厉医药技术有限公司1CXHL2500211Afuresertib片来凯制药(宁波)有限公司1CXHL2500210Afuresertib片来凯制药(宁波)有限公司1CXHL2500209VC005片江苏威凯尔医药科技股份有限公司1CXHL2500200SAL0140片深圳信立泰药业股份有限公司1CXHL2500196SAL0140片深圳信立泰药业股份有限公司1CXHL2500195AHB-137注射液杭州浩博医药有限公司1CXHL2500193MT-1207缓释片原研药港生命科学(辽宁)集团有限公司1CXHL2500191MT-1207缓释片原研药港生命科学(辽宁)集团有限公司1CXHL2500190MT-1207缓释片原研药港生命科学(辽宁)集团有限公司1CXHL2500189TJ0113胶囊杭州天玑济世生物科技有限公司1CXHL2500180UA026片祐森健恒生物医药(上海)有限公司1CXHL2500176UA026片祐森健恒生物医药(上海)有限公司1CXHL2500175FNX010片成都凡诺西生物医药科技有限公司1CXHL2500167FNX010片成都凡诺西生物医药科技有限公司1CXHL2500166HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500164HS-10542胶囊江苏豪森药业集团有限公司1CXHL2500160BTS0327江苏诺和必拓新药研发有限公司2.2CXHL2500192AQF直服颗粒深圳珐玛易药品科技有限公司2.2CXHL2500169PA9060乳膏安徽劳斯多斯医药科技有限公司2.2;2.4CXHL2500188PA9060乳膏安徽劳斯多斯医药科技有限公司2.2;2.4CXHL2500186DYTH201片山西德元堂药业有限公司2.3CXHL2500184DYTH201片山西德元堂药业有限公司2.3CXHL2500183BNT323映恩生物制药(苏州)有限公司1CXSL2500174注射用BGB-R046广州百济神州生物制药有限公司1CXSL2500166伏欣奇拜单抗注射液长春金赛药业有限责任公司1CXSL2500163BC006单抗注射液宝船生物医药科技(上海)有限公司1CXSL2500161注射用IBB0979盛禾(中国)生物制药有限公司1CXSL2500150注射用AS1501深圳市中科艾深医药有限公司1CXSL2500145自体淋巴细胞注射液康爱瑞浩生物医药(浙江)股份有限公司1CXSL2500131注射用KJ103上海宝济药业股份有限公司1CXSL2500128DNTH103注射液元羿生物科技(上海)有限公司1CXSL2500124NCR201注射液中盛溯源(广州)生物科技有限公司1CXSL2500126XS228细胞注射液士泽生物医药(苏州)有限公司1CXSL2500121仿制药申请药品名称企业注册分类受理号盐酸苯海拉明注射液扬州中宝药业股份有限公司3CYHS2501019注射用拉氧头孢钠山东宜和生物医药科技有限公司3CYHS2401826吸入用盐酸氨溴索溶液济南景笙科技有限公司3CYHS2401655布立西坦口服溶液海南全星制药有限公司3CYHS2401578盐酸丙美卡因滴眼液浙江莎普爱思药业股份有限公司3CYHS2401525乙酰半胱氨酸注射液成都瑞尔医药科技有限公司3CYHS2400664羧甲司坦口服溶液宁波卓仑医药科技有限公司3CYHS2301344羧甲司坦口服溶液宁波卓仑医药科技有限公司3CYHS2301343地西泮直肠凝胶特丰制药有限公司3CYHS2301173维生素B12滴眼液珠海同源药业有限公司4CYHS2402170亚叶酸钙注射液森淼(山东)药业有限公司4CYHS2401985阿奇霉素干混悬剂江苏东科康德药业有限公司4CYHS2401789甲磺酸艾立布林注射液浙江星月药物科技有限公司4CYHS2302300瑞卢戈利片成都倍特药业股份有限公司3CYHL2500042米诺地尔泡沫剂(男用)山东京卫制药有限公司3CYHL2500041乙酰唑胺缓释胶囊海南灵康制药有限公司3CYHL2500037贝派度酸依折麦布片江西施美药业股份有限公司3CYHL2500034甘露醇山梨醇注射液四川美大康佳乐药业有限公司3CYHL2500033进口申请药品名称企业注册分类受理号LOU064片Novartis Pharma AG1JXHL2500026LOU064片Novartis Pharma AG1JXHL2500025LOU064片Novartis Pharma AG1JXHL2500024Bleximenib片Janssen Research & Development, LLC1JXHL2500023Bleximenib片Janssen Research & Development, LLC1JXHL2500022Bleximenib片Janssen Research & Development, LLC1JXHL2500021TAK-279胶囊Takeda Development Center Americas, Inc.1JXHL2500018盐酸奎扎替尼片Daiichi Sankyo, Inc.5.1JXHL2500031盐酸奎扎替尼片Daiichi Sankyo, Inc.5.1JXHL2500030中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

申请上市临床申请

2025-05-03

·赛柏蓝

二甲双胍，又发现新作用！

作者 | 颜色来源 | 赛柏蓝二甲双胍，又有新作用。 01二甲双胍再添新证新作用+1？作为临床应用超百年的经典降糖药，二甲双胍几乎每隔一段时间就会被发现新作用。据赛柏蓝梳理，该药物目前已报道的潜质作用达40余项，涵盖抗衰老、心血管保护、改善代谢等多领域。业内有人称其为“神药”，但患者服用时应谨遵医嘱，合理用药。根据奇点网消息，近日，澳大利亚莫纳什大学的Flavia M. Cicuttini团队领衔完成的随机临床试验结果发表在《美国医学会杂志》，表明二甲双胍能够缓解超重或肥胖伴膝关节骨性关节炎患者的膝关节疼痛症状。研究结果显示，超重或肥胖伴膝关节骨性关节炎的患者连续半年服用2000mg/天的二甲双胍之后，膝关节疼痛和僵硬得到明显缓解，功能提高。美国贝勒大学医学院团队在Cell Reports Medicine期刊发表的研究成果就显示，以二甲双胍为代表的双胍类药物，对三阴性乳腺癌（TNBC）的影响实际上是剂量依赖性的，高剂量二甲双胍能有效抑癌，但由于二甲双胍的生物利用度低，按临床获批剂量来用药，反而会使二甲双胍在较低的药物浓度下助力癌细胞的脂肪酸β-氧化（FAO），抑癌变促癌。加拿大玛格丽特公主癌症中心的研究人员在Nature上发表了一篇题为“Metformin reduces the competitive advantage of Dnmt3aR878H HSPCs”的研究论文，结果显示，突变造血干细胞的线粒体呼吸作用更强，从而具有更强的生长优势，而二甲双胍能够通过抑制线粒体呼吸作用，选择性降低突变造血干细胞的竞争优势，降低克隆性造血相关的疾病，包括血癌和其他与年龄相关的炎症性疾病等。诞生100多年的二甲双胍，在我国已有30多年的临床应用经验，在糖尿病治疗领域占据重要地位，其不断拓展的治疗潜力与临床应用争议始终相伴相生。《中国2型糖尿病防治指南（2020年版）》指出，二甲双胍为2型糖尿病患者高血糖的一线治疗选择；《二甲双胍临床应用专家共识（2023 年版）》指出，在无相关心肾保护的强适应证的情况下，二甲双胍应作为新诊断2型糖尿病控制高血糖的一线用药和降糖药物联合治疗的基础用药。赛柏蓝不完全梳理发现，二甲双胍还存在不少潜质作用，如减肥、抗衰老、逆转生物年龄、防雾霾、协助戒烟、抗炎、改善多囊卵巢综合征、心血管保护作用、改善肠道菌群等。不过，二甲双胍的大部分潜质作用还在继续研究中，最终效果还需进一步确定。赛柏蓝制图目前，二甲双胍已发展出普通片剂、肠溶制剂、缓释片等多种剂型，并与不同药物组成固定复方制剂，为个性化治疗提供更多选择。02集采重塑格局复方制剂成新战场赛柏蓝查询发现，以“二甲双胍”为关键词的相关批文已经有425条。相较于2024年9月16日赛柏蓝查询到的367条，又多了58条，大批知名药企入局。二甲双胍在中国市场正面临前所未有地激烈竞争。米内网数据显示，2020年该药在中国公立医疗机构终端的销售额高达62亿元，持续领跑非胰岛素类降糖药市场。第三批国采中，二甲双胍口服常释剂型（0.5g规格）的价格从集采前的每片0.4元降至6分钱左右，日均费用从1.6元降至0.24元；缓释剂型的价格从每片0.7元降至0.1元左右，日均费用从2.8元降至0.4元。而后，二甲双胍还陆续进入国采续标中，如十三省(区、兵团)联盟药品采购，二甲双胍国采续标价格提升。不过，在今年1月广东公示广东联盟阿哌沙班片等药品集中带量采购拟中选结果的通知中，依旧出现了3分钱的二甲双胍。国家医保局表示，集采后，2023年全国医疗机构使用二甲双胍集采中选药品114亿片，其中0.25g规格的用量为46亿片，0.5g规格的用量为68亿片，中选二甲双胍用量占该药品总用量的84%。随着仿制药一致性评价的推进，国家药监局仅以“盐酸二甲双胍片”为关键词的相关信息已经有120条。二甲双胍作为2型糖尿病治疗的“金标准”，不仅被国内外指南推荐为首选药物，还在联合用药中占据核心地位。然而，其潜力远不止于此。复方降糖药市场从2019年的8亿元规模上涨至2021年的超22亿元规模，复方制剂成新趋势。二甲双胍复方制剂市场竞争激烈，如西格列汀二甲双胍和吡格列酮二甲双胍等，特别是在达格列净二甲双胍缓释片这一品种上。达格列净二甲双胍缓释片原研是阿斯利康，这一药物于2023年6月在中国获批上市，并已纳入医保乙类支付。其在2023年全球市场的销售量约20亿片，销售额约16亿美元。国内上市一年多后，其便迎来了仿制药。2024年9月，宣泰医药的达格列净二甲双胍缓释片获批上市，成为该品种国内首家获批的仿制药；随后，南京正大天晴达格列净二甲双胍缓释片获批上市......目前国内还有大批仿制药企业提交了达格列净二甲双胍缓释片的上市申请。随着批文数量不断增加、集采持续深化，药企需在剂型创新、复方开发等持续发力。未来，二甲双胍能否在新领域取得突破，值得持续关注。END内容沟通：郑瑶（13810174402）

2025-05-03

·药通社

第五家申请上市，原研获批仅15天！

2025年04月14日，日本兴和制药的佩玛贝特片在中国获批上市，用于治疗高脂血症（包括家族性高脂血症）。药通社曾预测该品种仿制跟进速度会极其快，详见：原研刚上市，21家企业抢首仿！但没想到，这速度远比想象中还要快。仅一天后，4月23日，南京正大天晴首家提交仿制上市申请，随后七天内，又接连有4家企业提交了上市申请。短短一周多，已有五家提交了上市申请：首家仿制上市申请被受理的日期与NMPA发布原研批准件日期相差仅9天。这个时间差创造了新纪录，首次有企业仿制上市受理日期与原研获批日期相隔在10天以内，加上中间双休日，受理等待等，实际准备注册资料时间预计只有5天，这个速度真的是吓人。目前国内对于首仿药品的政策倾斜力度其实并不大，抢仿更多还是用来体现企业的综合实力和宣传作用，毕竟业内会记得品种的首仿企业，但很难记得二仿、三仿企业。不过首家提交上市申请也不一定就是首仿企业，后来者抢占首仿可能性不小。比如近日同样被“围剿”的品种瑞舒伐他汀依折麦布片。赛诺菲的瑞舒伐他汀依折麦布片24年1月2日在国内上市，24年1月12日石家庄四药上市申请被受理，是首家上报，但首家过评企业却是第二家提交上市的福元医药（24年2月6日提交），目前石家庄四药的上市申请在尚在发补阶段。福元医药顺利抢走了石四药的首仿。由此看来，企业要想顺利抢到首仿，提交速度不是关键，资料及数据准备完全才是关键。再说回佩玛贝特片，这个确实是个好品种。有业内人士称，佩玛贝特是个非常被看好的品种，抗血脂市场极大，国内对非核心专利的无效申请已经得心应手，花一千万左右的CMC费用获得一个强势品种非常划算，前期成功案例挺多。但企业也需要冷静，该品种也并非完美无缺。佩玛贝特的核心竞争力体现在其对甘油三酯（TG）的显著降低效果，另外对于医生和患者而言，吸引力在于其安全性，传统贝特类药物可能引起肝功能异常或肌酸激酶升高，而佩玛贝特在中国3期临床试验中显示，使用佩玛贝特后ALT、AST等肝脏指标反而有所下降，且对肾功能损害患者无需调整剂量。效果好，副作用小，看起来是个完美药物，但佩玛贝特有一个严重指标缺陷，那就是心血管事件（如心梗、中风）发生率，无任何证据证明佩玛贝特能降低心血管时间的发生率。这一结果与传统认知相悖——长期以来，降低TG和提升HDL-C被视为预防心血管疾病的关键策略，为何指标改善未能转化为临床获益？这就需要更多的临床试验来解释了。在心血管获益方面的不确定性，势必会左右医生和患者的选择。如果企业真的要入局此品种，还是需要考虑到此缺陷。↓扫码加入药通社交流群 ↓投稿/企业合作/内容沟通：华籍美人（Ww_150525）*添加请注明备注及来意

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