最近更新 | Last Updated: 2023-05-23
| Biosimilar 生物类似药 |
Applicant 申请人 |
Ref. Product 参考药品 |
RPS 参考药开发商 |
Registered Patents 参考药登记专利1 |
Generic Certification 专利声明类型2 |
NMPA Approval 药监局批准日期 |
Launch Date 上市日期 |
| 贝伐珠单抗注射液 TQ-B2302 |
Chia Tai Tianqing Pharmaceutical 正大天晴 |
AVASTIN® (bevacizumab) | Roche 罗氏 |
N/A | Type 1 | 1类 | 2023-02-28 | |
| 托珠单抗注射液 施瑞立® （BAT1806） |
Bio-Thera Solutions 百奥泰生物 |
ACTEMRA® (tocilizumab) | Roche 罗氏 |
ZL02807784.9 ZL2004800 11401.1 ZL20151100 4468.9 |
Type 3 | 3类 Type 4.1 | 4.1类 Type 4.2| 4.2类 |
2023-01-16 | |
| 注射用曲妥珠单抗 | Anhui Anke Biotechnology 安科生物 |
HERCEPTIN® (trastuzumab) |
Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 地舒单抗注射液 | Qilu Pharmaceutical 齐鲁制药 |
XGEVA® (denosumab) |
Amgen 安进 |
ZL20131005 2370.5 |
Type 3 | 3类 | ||
| 地舒单抗注射液 LY06006 / BA6101 |
Boan Biotech 博安生物 |
XGEVA® (denosumab) |
Amgen 安进 |
ZL20131005 2370.5 |
Type 3 | 3类 | ||
| 利拉鲁肽注射液 | Huadong Medicine 华东医药 |
Victoza® (liraglutide) |
Novo Nordisk 诺和诺德 |
N/A | Type 1 | 1类 | ||
| 阿达木单抗注射液 SCT630 |
SinoCellTech 神州细胞工程 |
HUMIRA® (adalimumab) |
AbbVie 艾伯维 |
N/A | Type 1 | 1类 | ||
| 托珠单抗注射液 | 珠海市丽珠单抗生物 | ACTEMRA® (tocilizumab) |
Roche 罗氏 |
ZL02807784.9 ZL20048001 1401.1 ZL20151100 4468.9 |
Type 4.2| 4.2类 Type 4.1 | 4.1类 Type 4.1 | 4.1类 |
2023-01-18 | |
| 地舒单抗注射液 | 江苏泰康生物 | PROLIA® (denosumab) | Amgen 安进 |
ZL20131005 2370.5 |
Type 3 | 3类 | 2023-03-28 | |
| 重组人促卵泡激素注射液 LM001 |
康宁杰瑞 | GONAL-F® (follitropin alfa) |
Merck Serono 默克雪兰诺 |
N/A | Type 1 | 1类 | ||
| 利妥昔单抗注射液 | Chia Tai Tianqing Pharmaceutical 正大天晴 |
RITUXAN® (rituximab) |
Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 注射用曲妥珠单抗 | Zhejiang Hisun 海正药业 |
HERCEPTIN® (trastuzumab) |
Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 门冬胰岛素注射液 | 吉林惠升生物制药有限公司 | NOVOLOG® (insulin aspart injection) |
Novo Nordisk 诺和诺德 |
N/A | Type 1 | 1类 | ||
| 精蛋白人胰岛素混合注射液 | 宜昌东阳光长江药业股份有限公司 | NOVOLIN® 70/30 (human insulin isophane suspension and human insulin injection) |
Novo Nordisk 诺和诺德 |
N/A | Type 1 | 1类 | ||
| 注射用曲妥珠单抗 | Chia Tai Tianqing Pharmaceutical 正大天晴 |
HERCEPTIN® (trastuzumab) |
Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 注射用罗普司亭 | Qilu Pharmaceutical 齐鲁制药 |
ROMIPLATE® (romiplostim) |
Kyowa Kirin 協和醱酵麒麟 |
N/A | Type 1 | 1类 | ||
| 贝伐珠单抗注射液 SCT510 | SinoCellTech 神州细胞工程 |
AVASTIN® (bevacizumab) | Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 阿柏西普眼内注射溶液 | Qilu Pharmaceutical 齐鲁制药 |
EYLEA® (Aflibercept) |
Bayer 拜耳 |
N/A | Type 1 | 1类 | ||
| 利拉鲁肽注射液 | Tonghua Dongbao 通化东宝 |
VICTOZA® (Liraglutide) |
Novo Nordisk 诺和诺德 |
N/A | Type 1 | 1类 | ||
| 特立帕肽注射液 | GeneTech Pharm 博康健基因 |
FORSTEO® teriparatide |
Eli Lilly 礼来 |
N/A | Type 1 | 1类 | ||
| 注射用依那西普 | Qilu Pharmaceutical 齐鲁制药 |
ENBREL® (Etanercept) |
Pfizer Limited 辉瑞 |
N/A | Type 1 | 1类 | ||
| 德谷胰岛素注射液 | Hui Sheng Bio-Pharm 吉林惠升生物制药 |
TRESIBA® (insulin degludec) |
Novo Nordisk 诺和诺德 |
N/A | Type 3 | 3类 | ||
| 特立帕肽注射液 | United Biotech 上海联合赛尔生物 |
Forteo® (Teriparatide Injection) |
Eli Lilly 礼来 |
N/A | Type 1 | 1类 | ||
| 精蛋白锌赖脯胰岛素混合注射液（25R） | China Wanbang 江苏万邦生化医药 |
优泌乐25® (Mixed Protamine Zinc Recombinant Human Insulin Lispro Injection(25R)) |
Eli Lilly 礼来 |
N/A | Type 1 | 1类 | ||
| 特立帕肽注射液 | Hebang Biotech 无锡和邦生物科技 |
Forteo® (Teriparatide Injection) |
Eli Lilly 礼来 |
N/A | Type 1 | 1类 | ||
| 甘精胰岛素注射液 | Hefei Tianmai Biotech 合肥天麦生物科技 |
Insulin Glargine Injection | Sanofi-Aventis 赛诺菲 |
N/A | Type 1 | 1类 | ||
| 利拉鲁肽注射液 | Chia Tai Tianqing Pharmaceutical 正大天晴 |
VICTOZA® (Liraglutide) |
Novo Nordisk 诺和诺德 |
N/A | Type 1 | 1类 | ||
| 利妥昔单抗注射液 | Sun-ho Bio 盛禾生物制药 |
RITUXAN® (rituximab) |
Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 利妥昔单抗注射液 | 上海生物制品研究所有限责任公司 | RITUXAN® (rituximab) |
Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 甘精胰岛素注射液 | Eli Lilly Netherland B.V. | Insulin Glargine Injection | Sanofi-Aventis 赛诺菲 |
N/A | Type 1 | 1类 | ||
| 托珠单抗注射液 | 金宇博沃润泽生物技术有限公司 | ACTEMRA® (tocilizumab) | Roche 罗氏 |
ZL02807784.9 ZL20048001 1401.1 ZL20151100 4468.9 |
Type 3 | 3类 Type 4.1 | 4.1类 Type 4.2 | 4.2类 |
||
| 帕妥珠单抗注射液 | Qilu Pharmaceutical 齐鲁制药 |
PERJETA® (pertuzumab) | Roche 罗氏 |
ZL20121000 6776.5 ZL20068001 3738.5 ZL20098011 1007.8 ZL20058003 1905.4 |
Type 4.2 | 4.2类 Type 4.2 | 4.2类 Type 2 | 2类 Type 4.2 | 4.2类 |
||
| 雷珠单抗注射液 | Qilu Pharmaceutical 齐鲁制药 |
LUCENTIS® (ranibizumab) | Novartis 诺华 |
N/A | Type 1 | 1类 | ||
| 托珠单抗注射液 | 海正生物制药 | ACTEMRA® (tocilizumab) | Roche 罗氏 |
ZL02807784.9 ZL20048001 1401.1 ZL20151100 4468.9 ZL2020100 40597.8 |
Type 3 | 3类 Type 3 | 3类 Type 3 | 3类 Type 3 | 3类 |
2023-02-28 | |
| 地舒单抗注射液 | 菲洋生物技术 | PROLIA® (denosumab) |
Amgen 安进 |
N/A | Type 3 | 3类 | ||
| 地舒单抗注射液 | 山东博安生物技术 | PROLIA® (denosumab) | Amgen 安进 |
ZL20131005 2370.5 |
Type 2 | 2类 | ||
| 注射用曲妥珠单抗 | Qilu Pharmaceutical 齐鲁制药 |
HERCEPTIN® (trastuzumab) | Roche 罗氏 |
N/A | Type 1 | 1类 | ||
| 德谷门冬双胰岛素注射液 | Hui Sheng Bio-Pharm 吉林惠升生物制药 |
TRESIBA® (insulin degludec) |
Novo Nordisk 诺和诺德 |
N/A | Type 3 | 3类 | ||
| 聚乙二醇化重组人粒细胞刺激因子注射液 | 杭州九源基因工程有限公司 | NEULASTA® (pegfilgrastim, PEG-rhG-CSF) |
Amgen 安进 |
CN95191454.5 | Type 2 | 2类 |
1 China has implemented a patent linkage system in its amended patent law, which became effective June 1, 2021 (Article 76 of the Patent Law of the People’s Republic of China (2020)), and released the “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)” (药品专利纠纷早期解决机制实施办法 (试行), hereinafter, the “Measures”) on July 4, 2021. A patent registration platform has been established for the Marketing Authorization Holder (MAH) to register certain patents applicable to the approved drug product. For biologics, patents may be registered include those directed to the active pharmaceutical ingredient (API) sequence/structure information and medical use. 于 2021 年 6 月 1 日生效的新修正的《中华人民共和国专利法》第七十六条引入药品专利纠纷早期解决的有关规定（专利链接制度）。根据2021年7月4日发布的《药品专利纠纷早期解决机制实施办法（试行）》（以下简称《办法》），建立中国上市药品专利信息登记平台，用于相关药品专利信息登记与主动公开。生物制品可登记活性成分的序列结构专利、医药用途专利。
2 According to the Measures, for registered patents on approved biologics, biosimilar applicants need to make a patent certificate of any of the following types: (1) There is no relevant patent registered; (2) The registered patent has expired or has been declared invalid or the biosimilar applicant has a license; (3) There is a registered patent and the biosimilar applicant will not market the drug until expiration of the patent; and (4) There is a registered patent on the platform, but it should be invalid, or it does not cover the biosimilar. 根据《办法》，申请人提交生物类似药上市注册申请时需提交以下任一类型的专利声明： 1类声明：中国上市药品专利信息登记平台中没有被仿制药的相关专利信息；2类声明：中国上市药品专利信息登记平台收录的被仿制药相关专利权已终止或者被宣告无效，或者仿制药申请人已获得专利权人相关专利实施许可；3类声明：中国上市药品专利信息登记平台收录有被仿制药相关专利，仿制药申请人承诺在相应专利权有效期届满之前所申请的仿制药暂不上市；4类声明：中国上市药品专利信息登记平台收录的被仿制药相关专利权应当被宣告无效，或者其仿制药未落入相关专利权保护范围。