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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 328 drug applications between 10 November 2023 and 16 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.

2023/11/10 – 2023/11/16

Period
2023/11/10 to 2023/11/16, 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
328
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
1

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

328filings, 65 of them generic

By application type

Application typeFilings
Supplement189
Generic65
New drug40
Import21
Unspecified9
Import re-registration4

By drug type

Drug typeFilings
Chemical drug228
TCM62
Therapeutic biologic34
Biologic3
Prophylactic biologic1

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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules634
2Neostigmine Methylsulfate Injection524
3Ethyl Iosapentate Capsules2127
4Etoricoxib Tablets218
5Vonoprazan Fumarate Tablets2160
6Famotidine Injection218
7注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name212
8Minoxidil Liniment2152
9Vitamin K1 Injection216
10Dacomitinib Tablets210

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Shuang Yan Pharma Co., Ltd. romanized41400
2Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized1140
3AstraZeneca AB840
4Jiu Hua Hua Yuan Pharma Co., Ltd. romanized770
5Bao Guang Pharma (Chengdu) Co., Ltd. romanized550
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD510
7Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
8Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized430
9Hangzhou Minsheng Pharmaceutical Co., Ltd424
10Guangzhou Yin Nuo Pharmaceuticals Group Co., Ltd. romanized410

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

91 this week

AcceptedDrugApplicants
2023/11/16Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2303146 Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/11/16Generic · Class 3 Metformin Hydrochloride Extended-release TabletsCYHS2303145 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2023/11/16New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2300784 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/11/16New drug · Class 1 TQB2928注射液 · No verified English nameCXSL2300783 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/11/16New drug · Class 1 LF0376片 · No verified English nameCXHL2301273 Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/15Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2300196 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/11/15Import · Class 1 AZD5305 · No verified English nameJXHL2300290 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/15Import · Class 1 AZD5305 · No verified English nameJXHL2300289 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/15Import · Class 1 AZD5305 · No verified English nameJXHL2300288 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/15Import · Class 1 AZD5305 · No verified English nameJXHL2300287 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/11/15Import · Class 1 AZD9833片 · No verified English nameJXHL2300286 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2023/11/15Import · Class 1 Baxdrostat片 · No verified English nameJXHL2300285 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/11/15Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2300284 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/11/15Import · Class 1 Baxdrostat片 · No verified English nameJXHL2300283 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/11/15Import · Class 2.2; 2.4 Ganaxolone注射剂 · No verified English nameJXHL2300282 Marinus Pharmaceuticals Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd
2023/11/15Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303141 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2023/11/15Generic · Class 3 Famotidine InjectionCYHS2303140 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized
2023/11/15Generic · Class 3 Famotidine InjectionCYHS2303139 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized
2023/11/15Generic · Class 3 Heparin Sodium InjectionCYHS2303138 Suzhou Erye Pharmaceutical Co., Ltd
2023/11/15Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2303137 Yunnan Xian Shi Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/11/15Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2303136 Yunnan Xian Shi Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2023/11/15Generic · Class 3 Bumetanide InjectionCYHS2303128 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/11/15Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHL2300138 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2023/11/15New drug · Class 1 TQB2916注射液 · No verified English nameCXSL2300782 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/11/15New drug · Class 1 舒西利单抗注射液 · No verified English nameCXSL2300781 Hainan Sai Le Min Bio Technology Co., Ltd. romanized
2023/11/15New drug · Class 1 SCT650C 注射液 · No verified English nameCXSL2300780 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2023/11/15New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2300779 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/11/15New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301272 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/11/15New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301271 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/11/15New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301270 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD

61 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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