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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 97 drug applications between 11 May 2022 and 17 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 15, covering 12 drug names.

2022/05/11 – 2022/05/17

Period
2022/05/11 to 2022/05/17, 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
97
Drugs with new generic filings (by drug name, de-duplicated)
12
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

97filings, 15 of them generic

By application type

Application typeFilings
Supplement60
Generic15
New drug10
Import10
Unspecified1
Import re-registration1

By drug type

Drug typeFilings
Chemical drug87
Therapeutic biologic5
TCM4
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

12 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1中/长链脂肪乳注射液(C6~24) · No verified English name210
2盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
3Dapagliflozin Tablets2184
4Diacerein Capsules113
5Tenofovir alafenamide Fumarate Tablets110
6Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution1123
7氯雷他定糖浆 · No verified English name117
8Mecobalamin Tablets1116
9Ambroxol Hydrochloride Tablets113
10Fudosteine oral solution117

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

50 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Fu Ren Huai Qing Tang Pharmaceutical Co., Ltd. romanized19170
2Shandong Qidu Pharmaceutical Co., Ltd.430
3Meiji Seika Pharma Co. Ltd.410
4Zhejiang Jin Fang Pharma Co., Ltd. romanized410
5Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized330
6Topfond Pharmaceutical Co., Ltd.320
7Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized220
8Chongqing Xi Er An Pharma Co., Ltd. romanized220
9AstraZeneca AB210
10Bio Products Laboratory Limited210

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

22 this week

AcceptedDrugApplicants
2022/05/13Import · Class 1 Linzagolix片 · No verified English nameJXHL2200113 Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd.
2022/05/13Import · Class 1 Linzagolix片 · No verified English nameJXHL2200112 Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd.
2022/05/13Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2200733 Chengdu Shuo De Pharma Co., Ltd. romanized
2022/05/13New drug · Class 3.3 ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2200213 Liaoning Cheng Da Bio Co., Ltd. romanized; Beijing Cheng Da Tian He Bio Technology Co., Ltd. romanized; Cheng Da Bio (Ben Xi) Co., Ltd. romanized
2022/05/13New drug · Class 2.4 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2200307 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2022/05/12Import · Class 1 PF-07104091片 · No verified English nameJXHL2200111 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/05/12Import · Class 1 PF-07104091片 · No verified English nameJXHL2200110 Pfizer Inc.; Pfizer Investment CO. Ltd
2022/05/12Import · Class 1 Liafensine片 · No verified English nameJXHL2200109 Denovo Biopharma LLC; Denovo Biopharma Co. Ltd.
2022/05/12Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200731 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2022/05/12New drug · Class 1 CM310重组人源化单克隆抗体注射液 · No verified English nameCXSL2200212 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2022/05/12New drug · Class 1 GFH018 片 · No verified English nameCXHL2200306 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2022/05/12New drug · Class 1 GFH018 片 · No verified English nameCXHL2200305 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2022/05/12New drug · Class 1 GFH018 片 · No verified English nameCXHL2200304 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2022/05/12New drug · Class 1 GFH018 片 · No verified English nameCXHL2200303 Zhejiang Jin Fang Pharma Co., Ltd. romanized
2022/05/11Import · Class 1 Cotadutide注射液 · No verified English nameJXHL2200108 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/05/11Import · Class 1 Cotadutide注射液 · No verified English nameJXHL2200107 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2022/05/11Generic · Class 3 Fudosteine oral solutionCYHS2200723 Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2022/05/11Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200722 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2022/05/11Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2200721 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2022/05/11New drug · Class 1 注射用ZB001 · No verified English nameCXSL2200210 Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized
2022/05/11New drug · Class 2.2 盐酸多奈哌齐口腔速溶膜 · No verified English nameCXHL2200300 Sichuan Bai Li Pharma Co., Ltd. romanized
2022/05/11New drug · Class 2.2 盐酸多奈哌齐口腔速溶膜 · No verified English nameCXHL2200299 Sichuan Bai Li Pharma Co., Ltd. romanized

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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