YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 186 drug applications between 20 September 2021 and 26 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 18 drug names.

2021/09/20 – 2021/09/26

Period
2021/09/20 to 2021/09/26, 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
186
Drugs with new generic filings (by drug name, de-duplicated)
18
Accepted this week, now under review
0

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

186filings, 25 of them generic

By application type

Application typeFilings
Supplement109
New drug31
Generic25
Import8
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug129
Therapeutic biologic29
TCM23
Biologic4
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Clindamycin Injection314
2Esomeprazole Magnesium for Delayed-release Oral Suspension314
3Dopamine Hydrochloride Injection223
4Ibuprofen Suspension2114
5Felodipine Sustained Release Tablets211
6Compound α-Ketoacid Tablets110
7Levofloxacin and Sodium Chloride Injection1114
8Levofloxacin Tablets117
9Posaconazole Oral Suspension113
10Roxatidine Acetate Hydrochloride For Injection115

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

95 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized1780
2Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized1010
3Sai Ling Pharma Technology Group Co., Ltd. romanized980
4Kyowa Kirin Co. Ltd610
5Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized610
6Hubei Ye Zhen Tang Pharma Co., Ltd. romanized550
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized520
8Bristol-Myers Squibb Pharma EEIG510
9Upjohn US 2 LLC410
10AstraZeneca AB320

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

47 this week

AcceptedDrugApplicants
2021/09/26Import · Class 1 VAY736注射液 · No verified English nameJXSL2101110 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/09/26Import · Class 2.4 Vericiguat片 · No verified English nameJXHL2101186 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/09/26Import · Class 2.4 Vericiguat片 · No verified English nameJXHL2101185 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/09/26Import · Class 2.4 Vericiguat片 · No verified English nameJXHL2101184 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/09/26Import · Class 1 LOU064片 · No verified English nameJXHL2101183 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/09/26Generic · Class 3 Clindamycin InjectionCYHS2101784 Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2021/09/26Generic · Class 3 Clindamycin InjectionCYHS2101783 Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2021/09/26Generic · Class 3 Clindamycin InjectionCYHS2101782 Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2021/09/26Generic · Class 3 Compound α-Ketoacid TabletsCYHS2101780 Zhejiang AngLiKang Pharmaceutical CO.,LTD.
2021/09/26Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101779 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized
2021/09/26Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101778 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized
2021/09/26Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2101777 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized
2021/09/26Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2101771 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/09/26Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2101770 Hong He Pharmaceutical Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized
2021/09/26New drug · Class 2.3 荆防合剂 · No verified English nameCXZL2101027 Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized
2021/09/26New drug · Class 1 凯得宁单抗注射液 · No verified English nameCXSS2101032 Kang Fang Pharma Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/09/26New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSL2101343 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101342 Tai Zhou Han Zhong Biopharmaceuticals Co., Ltd. romanized
2021/09/26New drug · Class 1 注射用MRG002 · No verified English nameCXSL2101341 Shanghai Mei Ya Ke Bio Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2101334 Guangzhou Sai Juan Bio Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 LVGN6051单克隆抗体注射液 · No verified English nameCXSL2101332 Li Jin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2021/09/26New drug · Class 1 KL290052胶囊 · No verified English nameCXHL2101510 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/09/26New drug · Class 1 KL290052胶囊 · No verified English nameCXHL2101509 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2021/09/26New drug · Class 1 IPG1094片 · No verified English nameCXHL2101508 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 IPG1094片 · No verified English nameCXHL2101507 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 IPG1094片 · No verified English nameCXHL2101506 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/26New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2101505 Hangzhou He Er Si Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 IPG1094片 · No verified English nameCXHL2101504 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 IPG1094片 · No verified English nameCXHL2101503 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/26New drug · Class 1 IPG1094片 · No verified English nameCXHL2101502 Nanjing Ai Mei Fei Biopharmaceuticals Technology Co., Ltd. romanized

17 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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