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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 279 drug applications between 5 June 2022 and 11 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 30, covering 16 drug names.

2022/06/05 – 2022/06/11

Period
2022/06/05 to 2022/06/11, 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
279
Drugs with new generic filings (by drug name, de-duplicated)
16
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

279filings, 30 of them generic

By application type

Application typeFilings
Supplement176
New drug43
Generic30
Import19
Unspecified6
Import re-registration5

By drug type

Drug typeFilings
Chemical drug167
Therapeutic biologic65
TCM41
Biologic3
Prophylactic biologic3

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

16 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Atomoxetine Hydrochloride Capsules716
2复方聚乙二醇电解质散(Ⅲ) · No verified English name331
3Olanzapine Tablets314
4Olmesartan Medoxomil Tablets211
5Tandospirone Citrate Tablets212
6Oseltamivir Phosphate For Oral Suspension212
7Rocuronium Bromide Injection211
8复方聚乙二醇电解质散(III) · No verified English name113
9Olanzapine Orally Disintegrating Tablets110
10泊沙康唑注射液 · No verified English name111

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

139 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Kai Feng Pharmaceutical (Group) Co., Ltd. romanized23200
2Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized2170
3Zhejiang Ao Tuo Kang Pharmaceuticals Technology Co., Ltd. romanized970
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized880
5Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized750
6ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.717
7Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized660
8Novo Nordisk A/S620
9Guangxi Ji Min Tang Pharma Co., Ltd. romanized440
10F. Hoffmann-La Roche Ltd430

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

65 this week

AcceptedDrugApplicants
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200082 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200081 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200080 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200079 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 1 CagriSema注射液 · No verified English nameJXSL2200078 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2022/06/10Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2200077 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/06/10Import · Class 1 MK-4830注射液 · No verified English nameJXSL2200076 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/06/10Import · Class 1 BI 907828片 · No verified English nameJXHL2200139 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Import · Class 1 BI 907828片 · No verified English nameJXHL2200138 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Import · Class 1 BI 907828片 · No verified English nameJXHL2200137 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2022/06/10Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200858 Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2022/06/10Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2200857 Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized
2022/06/10New drug · Class 1.1 小儿香薷颗粒 · No verified English nameCXZL2200026 Yi Li Pharmaceutical Co., Ltd. romanized
2022/06/10New drug · Class 1 ZS801注射液 · No verified English nameCXSL2200261 Sichuan Zhi Shan Wei Xin Bio Technology Co., Ltd. romanized
2022/06/10New drug · Class 1 HB0036注射液 · No verified English nameCXSL2200260 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2022/06/10New drug · Class 1 注射用ZGGS18 · No verified English nameCXSL2200259 Name not romanized
2022/06/10New drug · Class 1 SYHX2009片 · No verified English nameCXHL2200374 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/06/10New drug · Class 1 SYHX2009片 · No verified English nameCXHL2200373 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2022/06/10New drug · Class 1 QY101软膏 · No verified English nameCXHL2200372 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/06/10New drug · Class 1 QY101软膏 · No verified English nameCXHL2200371 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/06/10New drug · Class 1 QY101软膏 · No verified English nameCXHL2200370 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/06/10New drug · Class 1 QY101软膏 · No verified English nameCXHL2200369 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2022/06/10New drug · Class 1 SAL0112片 · No verified English nameCXHL2200368 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/06/10New drug · Class 1 SAL0112片 · No verified English nameCXHL2200367 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/06/10New drug · Class 1 SAL0112片 · No verified English nameCXHL2200366 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/06/09Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2200075 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/09Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2200074 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/09Import · Class 1 CHF6001吸入粉雾剂 · No verified English nameJXHL2200136 Chiesi Farmaceutici S.p.A.; ICON Clinical Research (Beijing No.2) Co. Ltd.
2022/06/09Import · Class 1 CHF6001吸入粉雾剂 · No verified English nameJXHL2200135 Chiesi Farmaceutici S.p.A.; ICON Clinical Research (Beijing No.2) Co. Ltd.
2022/06/09Import · Class 1 LNP023胶囊 · No verified English nameJXHL2200134 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.

35 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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