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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 371 drug applications between 9 November 2023 and 15 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 57 drug names.

2023/11/09 – 2023/11/15

Period
2023/11/09 to 2023/11/15, 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
371
Drugs with new generic filings (by drug name, de-duplicated)
57
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

371filings, 85 of them generic

By application type

Application typeFilings
Supplement203
Generic85
New drug44
Import23
Unspecified9
Import re-registration7

By drug type

Drug typeFilings
Chemical drug260
TCM79
Therapeutic biologic30
Biologic1
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Granules634
2Neostigmine Methylsulfate Injection524
3Ibuprofen Injection328
4Potassium Chloride Oral Solution3211
5Minoxidil Liniment3252
6Olmesartan Medoxomil and Amlodipine Besylate Tablets222
7Ethyl Iosapentate Capsules2127
8Etoricoxib Tablets218
9复方醋酸钠林格注射液 · No verified English name212
10多种微量元素注射液(I) · No verified English name211

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

201 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
3Jiu Hua Hua Yuan Pharma Co., Ltd. romanized880
4AstraZeneca AB840
5CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD820
6Bao Guang Pharma (Chengdu) Co., Ltd. romanized550
7Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized440
8Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized440
9Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
10Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized430

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

113 this week

AcceptedDrugApplicants
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
2023/11/15New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301269 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/11/15New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2301268 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/11/15New drug · Class 1 LT-002-158片 · No verified English nameCXHL2301267 Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/15New drug · Class 1 LT-002-158片 · No verified English nameCXHL2301266 Shanghai Ling Tai Biopharmaceuticals Technology Co., Ltd. romanized
2023/11/14Import · Class 3.1 注射用利纳西普(暂定) · No verified English nameJXSS2300084 Kiniksa Pharmaceuticals (UK),Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD

83 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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