YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 430 drug applications between 10 July 2026 and 16 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 58, covering 45 drug names.

2026/07/10 – 2026/07/16

Period
2026/07/10 to 2026/07/16, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
430
Drugs with new generic filings (by drug name, de-duplicated)
45
Accepted this week, now under review
142

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

430filings, 58 of them generic

By application type

Application typeFilings
Supplement266
Generic58
New drug58
Import24
Unspecified16
Import re-registration8

By drug type

Drug typeFilings
Chemical drug209
TCM142
Therapeutic biologic70
Biologic5
Prophylactic biologic4

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ethyl Iosapentate Capsules3227
2Brivaracetam Tablets3119
3瑞维那新吸入溶液 · No verified English name2253
4Buprenorphine Transdermal Patches216
5Oxaliplatin Injection214
6Baricitinib Tablets2132
7Cefuroxime Sodium for Injection218
8Hydrocortisone Sodium Succinate for Injection2116
9甲苯磺酸卢美哌隆胶囊 · No verified English name212
10Bromhexine Hydrochloride Oral Solution2122

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

268 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Ao Er Pharma Co., Ltd. romanized990
2Pfizer Inc.810
3Les Laboratoires Servier640
4Amgen Inc.610
5Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized610
6Shanxi Huang He Zhong Yao Co., Ltd. romanized550
7Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized540
8Topfond Pharmaceutical Co., Ltd.540
9An Kang Zheng Da Pharmaceutical Co., Ltd. romanized540
10Novo Nordisk A/S520

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

110 this week

AcceptedDrugApplicants
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600169 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600168 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600167 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600166 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2601703 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2026/07/16Generic · Class 3 Brivaracetam TabletsCYHS2601699 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/07/16Generic · Class 3 Brivaracetam TabletsCYHS2601698 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/07/16Generic · Class 3 Brivaracetam TabletsCYHS2601697 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/07/16New drug · Class 3.3 精蛋白锌重组赖脯胰岛素混合注射液(25R) · No verified English nameCXSS2600108 Tong Hua Dong Bao Pharma Co., Ltd. romanized
2026/07/16New drug · Class 1 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600107 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/07/16New drug · Class 1 泰利奇拜单抗注射液(皮下注射) · No verified English nameCXSS2600106 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/07/16New drug · Class 1 恩维曲妥珠单抗注射液 · No verified English nameCXSS2600105 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized; Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. (You Xiao Zai He - Lian Jie Zi) romanized; Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. (Formulations) romanized
2026/07/16New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600740 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2026/07/16New drug · Class 1 GB261注射液 · No verified English nameCXSL2600739 Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized
2026/07/16New drug · Class 1 GB20注射液 · No verified English nameCXSL2600738 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2026/07/16New drug · Class 1 KR25102片 · No verified English nameCXHL2600864 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2026/07/16New drug · Class 2.4 利厄替尼片 · No verified English nameCXHL2600863 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2026/07/16New drug · Class 1 ASKC202片 · No verified English nameCXHL2600862 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2026/07/16New drug · Class 1 ASKC202片 · No verified English nameCXHL2600861 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2026/07/16New drug · Class 1 JYP0035胶囊 · No verified English nameCXHL2600860 Jia Yue (Chengdu) Pharmaceuticals Technology Co., Ltd. romanized
2026/07/16New drug · Class 2.2 YT628 · No verified English nameCXHL2600859 Ningxia Kang Ya Pharma Co., Ltd. romanized
2026/07/16New drug · Class 1 DAT-6618片 · No verified English nameCXHL2600858 Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized
2026/07/16New drug · Class 1 DAT-6618片 · No verified English nameCXHL2600857 Beijing Dan Qing Pharmaceuticals Technology Co., Ltd. romanized
2026/07/15Import · Class 1 Lunsekimig注射液 · No verified English nameJXSL2600165 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600276 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600275 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600274 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Import · Class 1 PF-08653944注射液 · No verified English nameJXHL2600273 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/07/15Generic · Class 3 Oxaliplatin InjectionCYHS2601692 Hefei Li Cheng Pharma Co., Ltd. romanized
2026/07/15Generic · Class 3 Oxaliplatin InjectionCYHS2601691 Hefei Li Cheng Pharma Co., Ltd. romanized

80 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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