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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 212 drug applications between 30 May 2022 and 5 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 30 drug names.

2022/05/30 – 2022/06/05

Period
2022/05/30 to 2022/06/05, 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
212
Drugs with new generic filings (by drug name, de-duplicated)
30
Accepted this week, now under review
2

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

212filings, 39 of them generic

By application type

Application typeFilings
Supplement116
Generic39
New drug28
Import19
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug146
TCM43
Therapeutic biologic17
Prophylactic biologic4
Biologic2

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

30 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Calcium Gluconate in Sodium Chloride Injection225
2Tadalafil Tablets2123
3Ornidazole Injection210
4Levetiracetam Tablets216
5Paliperidone Extend-release Tablets212
6Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
7Citicoline Sodium Injection213
8Metoprolol Tartrate Tablets213
9阿普米司特片 · No verified English name213
10Folic Acid Tablets1112

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

121 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Kai Feng Yu Gang Pharmaceutical Co., Ltd. romanized14130
2Jilin Rui Long Pharma Co., Ltd. romanized10100
3Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized770
4Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized770
5Qilu Pharmaceutical (Hainan) Co., Ltd432
6Shandong Run Ze Pharmaceutical Co., Ltd. romanized420
7Bristol-Myers Squibb Pharma EEIG410
8Novartis Pharma AG320
9Yi Chang Ren Fu Pharma Co., Ltd. romanized320
10Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized320

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

55 this week

AcceptedDrugApplicants
2022/06/03Import · Class 1 DS-1062a · No verified English nameJXSL2200072 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2022/06/03Import · Class 2.2 司库奇尤单抗注射液 · No verified English nameJXSL2200070 Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd.
2022/06/03Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2200069 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2022/06/03Import · Class 2.2 注射用罗特西普 · No verified English nameJXSL2200068 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2022/06/03Import · Class 1 AMG 193 · No verified English nameJXHL2200132 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 AMG 193 · No verified English nameJXHL2200131 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 AMG 193 · No verified English nameJXHL2200130 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2022/06/03Import · Class 1 Paltusotine片 · No verified English nameJXHL2200129 Crinetics Pharmaceuticals Inc.; WuXi Clinical Development Services (Shanghai) Co. Ltd.
2022/06/03Import · Class 1 Capivasertib · No verified English nameJXHL2200128 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2022/06/03Import · Class 1 Capivasertib · No verified English nameJXHL2200127 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2022/06/03Import · Class 1 MRTX849片 · No verified English nameJXHL2200126 Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2022/06/03Import · Class 1 LNP023胶囊 · No verified English nameJXHL2200125 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/06/03Import · Class 1 LNP023胶囊 · No verified English nameJXHL2200124 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/06/03Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2200834 Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized
2022/06/03Generic · Class 3 Flurbiprofen Sodium Eye DropsCYHS2200829 Wuhan Xian Lu Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Pusch Pharmaceutical Co., Ltd.
2022/06/03New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2200241 Nanjing Sai Nuo Biopharmaceutical Co., Ltd. romanized; Nanjing Sai Nuo Bio Technology Co., Ltd. romanized
2022/06/03New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2200240 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Xi Bei Min Zu University romanized
2022/06/03New drug · Class 2.2 苯甲酸氨氯地平干混悬剂 · No verified English nameCXHS2200032 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2022/06/03New drug · Class 2.2 苯甲酸氨氯地平干混悬剂 · No verified English nameCXHS2200031 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2022/06/03New drug · Class 1 AC-003胶囊 · No verified English nameCXHL2200358 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/06/03New drug · Class 1 AC-003胶囊 · No verified English nameCXHL2200357 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/06/03New drug · Class 1 TQB3702片 · No verified English nameCXHL2200356 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2022/06/03New drug · Class 1 VCT220片 · No verified English nameCXHL2200355 Suzhou Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2022/06/03New drug · Class 1 VCT220片 · No verified English nameCXHL2200354 Suzhou Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2022/06/03New drug · Class 1 SR750缓释片 · No verified English nameCXHL2200353 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2022/06/03New drug · Class 1 SR750缓释片 · No verified English nameCXHL2200352 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2022/06/03New drug · Class 1 ZN-B-2262片 · No verified English nameCXHL2200351 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2022/06/03New drug · Class 1 ZN-B-2262片 · No verified English nameCXHL2200350 Suzhou Zan Rong Pharmaceuticals Technology Co., Ltd. romanized
2022/06/02New drug · Class 1 QY201片 · No verified English nameCXHL2200349 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/06/02New drug · Class 1 QY201片 · No verified English nameCXHL2200348 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized

25 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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