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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 327 drug applications between 10 June 2022 and 16 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 49, covering 37 drug names.

2022/06/10 – 2022/06/16

Period
2022/06/10 to 2022/06/16, 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
327
Drugs with new generic filings (by drug name, de-duplicated)
37
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

327filings, 49 of them generic

By application type

Application typeFilings
Supplement184
Generic49
New drug46
Import29
Import re-registration12
Unspecified7

By drug type

Drug typeFilings
Chemical drug231
Therapeutic biologic58
TCM32
Biologic4
Prophylactic 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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olmesartan Medoxomil Tablets211
2Pravastatin Sodium Tablets212
3Pregabalin Capsules2112
4注射用头孢噻肟钠他唑巴坦钠 · No verified English name211
5Pantoprazole Enteric-Coated Tablets211
6Rasagiline Mesylate Tablets215
7Dopamine Hydrochloride Injection213
8Dapoxetine Hydrochloride Tablets2120
9Oseltamivir Phosphate For Oral Suspension212
10Minoxidil Topical Solution210

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Kai Feng Pharmaceutical (Group) Co., Ltd. romanized23200
2Novo Nordisk A/S1530
3Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized990
4Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized540
5Janssen-Cilag International NV530
6Qilu Pharmaceutical Co., Ltd.531
7Shenzhen Xin Li Tai Pharma Co., Ltd. romanized520
8Lian Cardiovascular Limited510
9Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized510
10LES LABORATOIRES SERVIER430

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

83 this week

AcceptedDrugApplicants
2022/06/16Import · Class 3.1 注射用Susoctocog alfa · No verified English nameJXSS2200020 Baxalta US Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; Takeda (China) International Trading Co. Ltd
2022/06/16Import · Class 1 JNJ-77242113-AAC片 · No verified English nameJXHL2200148 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/16Import · Class 2.4 Tacrolimus Eye DropsJXHL2200147 SENJU PHARMACEUTICAL CO. LTD.; Name not romanized
2022/06/16Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2200896 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/06/16Generic · Class 3 Minoxidil LinimentCYHS2200895 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/06/16Generic · Class 3 Fluorouracil InjectionCYHS2200893 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 1 重组抗CD20人源化单克隆抗体皮下注射液 · No verified English nameCXSL2200277 Shanghai Jiao Lian Drug Research and Development Co., Ltd. romanized
2022/06/16New drug · Class 1 TG103注射液 · No verified English nameCXSL2200276 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200275 Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 1 HXYT-001细胞注射液 · No verified English nameCXSL2200274 Hua Xia Ying Tai (Beijing) Bio Technology Co., Ltd. romanized; Beijing Qing Yi Tai Ke Pharmaceuticals Technology Co., Ltd. romanized
2022/06/16New drug · Class 1 尘螨过敏原舌下含片 · No verified English nameCXSL2200272 Ge Lin Mian Yi Ke Xue Co., Ltd. romanized
2022/06/16New drug · Class 1 尘螨过敏原舌下含片 · No verified English nameCXSL2200271 Ge Lin Mian Yi Ke Xue Co., Ltd. romanized
2022/06/16New drug · Class 1 尘螨过敏原舌下含片 · No verified English nameCXSL2200270 Ge Lin Mian Yi Ke Xue Co., Ltd. romanized
2022/06/16New drug · Class 1 JL14001注射液 · No verified English nameCXSL2200269 Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized
2022/06/16New drug · Class 1 注射用ASKG315 · No verified English nameCXSL2200268 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized
2022/06/16New drug · Class 2.2 盐酸替扎尼定口服溶液 · No verified English nameCXHL2200394 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 2.2 盐酸替扎尼定口服溶液 · No verified English nameCXHL2200393 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2022/06/16New drug · Class 1 D3S-001胶囊 · No verified English nameCXHL2200392 Name not romanized
2022/06/16New drug · Class 1 D3S-001胶囊 · No verified English nameCXHL2200391 Name not romanized
2022/06/16New drug · Class 2.3 恩格列净西格列汀二甲双胍缓释片 · No verified English nameCXHL2200390 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2022/06/16New drug · Class 1 QLH11811片 · No verified English nameCXHL2200388 Qilu Pharmaceutical Co., Ltd.
2022/06/16New drug · Class 1 QLH11811片 · No verified English nameCXHL2200387 Qilu Pharmaceutical Co., Ltd.
2022/06/16New drug · Class 1 QLH12007片 · No verified English nameCXHL2200377 Qilu Pharmaceutical Co., Ltd.
2022/06/16New drug · Class 1 AC176胶囊 · No verified English nameCXHL2200376 Bing Zhou Shi Bio Technology (Shanghai) Co., Ltd. romanized
2022/06/14Import · Class 2.2 度伐利尤单抗注射液 · No verified English nameJXSL2200085 MedImmune LLC; AstraZeneca Investment (China) Co. Limited
2022/06/14Import · Class 2.2 AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200146 Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/06/14Import · Class 2.2; 2.4 AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200145 Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/06/14Import · Class 2.2; 2.4 AV-101(伊马替尼)吸入粉雾剂 · No verified English nameJXHL2200144 Aerovate Therapeutics Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2022/06/14Generic · Class 3 Dexamethasone Sodium Phosphate InjectionCYHS2200883 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2022/06/14Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2200875 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized

53 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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