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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 205 drug applications between 25 June 2022 and 1 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 29 drug names.

2022/06/25 – 2022/07/01

Period
2022/06/25 to 2022/07/01, 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
205
Drugs with new generic filings (by drug name, de-duplicated)
29
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

205filings, 37 of them generic

By application type

Application typeFilings
Supplement81
New drug51
Generic37
Import13
Import re-registration12
Unspecified11

By drug type

Drug typeFilings
Chemical drug156
Therapeutic biologic28
TCM19
Biologic1
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

29 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets3220
2Tedizolid Phosphate Tablets221
3Norepinephrine Bitartrate Injection229
4Levofloxacin Injection211
5Empagliflozin Tablets2118
6盐酸多奈哌齐口崩片 · No verified English name210
7Atorvastatin Calcium Tablets2124
8Etoricoxib Tablets118
9Pentazocine Injection110
10Celecoxib Capsules115

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

127 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer AG660
2Hebei Wu Luo Pharma Co., Ltd. romanized660
3Hubei Kang Wei Yuan Pharma Co., Ltd. romanized660
4Ren He Yi Kang Group Co., Ltd. romanized640
5Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized610
6Suzhou Ya Sheng Pharma Co., Ltd. romanized420
7Novartis Pharma Schweiz AG410
8Pfizer Europe MA EEIG410
9Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized410
10Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized410

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

69 this week

AcceptedDrugApplicants
2022/06/30Generic · Class 3 Nicergoline TabletsCYHS2200980 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/06/30Generic · Class 3 Levofloxacin InjectionCYHS2200978 Changchun Hai Yue Pharma Co., Ltd. romanized
2022/06/30Generic · Class 3 Levofloxacin InjectionCYHS2200977 Changchun Hai Yue Pharma Co., Ltd. romanized
2022/06/30Generic · Class 3 Peramivir InjectionCYHS2200976 Suzhou Ai Mei Jin Pharmaceutical Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2022/06/30Generic · Class 3 Anagrelide Hydrochloride CapsulesCYHS2200937 Heilongjiang Tian Hong Pharma Co., Ltd. romanized
2022/06/30New drug · Class 1 RY_SW01细胞注射液 · No verified English nameCXSL2200303 Jiangsu Rui Yuan Bio Technology Co., Ltd. romanized
2022/06/30New drug · Class 1 KY-0118 注射剂 · No verified English nameCXSL2200302 Shanghai Ke Yi Pharma Technology Co., Ltd. romanized
2022/06/30New drug · Class 1 注射用贺普拉肽 · No verified English nameCXHL2200457 Shanghai He Pu Pharma Co., Ltd. romanized
2022/06/29Import · Class 2.2 Amivantamab注射液 · No verified English nameJXSL2200097 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/06/29Import · Class 1 FT-001注射液 · No verified English nameJXSL2200096 Frontera Therapeutics Inc.; Suzhou Frontera Therapeutics Co. Ltd.
2022/06/29Import · Class 1 BIIB122 · No verified English nameJXHL2200167 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/06/29Import · Class 2.4 Tazemetostat Hydrobromide片 · No verified English nameJXHL2200166 HUTCHMED (Hong Kong) Limited; HUTCHMED Limited
2022/06/29Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2200969 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/06/29New drug · Class 3.3 特立帕肽注射液 · No verified English nameCXSS2200062 Beijing Bo Kang Jian Ji Yin Technology Co., Ltd. romanized
2022/06/29New drug · Class 2.6 20价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2200300 Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized; Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized
2022/06/29New drug · Class 2.2 优替德隆胶囊 · No verified English nameCXHL2200456 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
2022/06/29New drug · Class 2.2 优替德隆胶囊 · No verified English nameCXHL2200455 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
2022/06/29New drug · Class 1 HMPL-689胶囊 · No verified English nameCXHL2200453 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2022/06/29New drug · Class 1 HMPL-689胶囊 · No verified English nameCXHL2200452 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2022/06/29New drug · Class 1 RBD7022注射液 · No verified English nameCXHL2200451 Suzhou Rui Bo Bio Technology Co., Ltd. romanized
2022/06/29New drug · Class 2.2 优替德隆胶囊 · No verified English nameCXHL2200450 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
2022/06/29New drug · Class 2.2 优替德隆胶囊 · No verified English nameCXHL2200449 Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized
2022/06/29New drug · Class 1 安喹利司片 · No verified English nameCXHL2200448 Zhongguo Yi Xue Ke College Drug Research Institute romanized; Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized
2022/06/29New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2200447 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2022/06/29New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2200446 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2022/06/29New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2200445 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2022/06/29New drug · Class 1 WXFL10030390片 · No verified English nameCXHL2200444 Shanghai Jia Tan Pharmaceuticals Technology Co., Ltd. romanized
2022/06/29New drug · Class 1 Tinlarebant 片 · No verified English nameCXHL2200417 Bei Liang Sheng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized
2022/06/28Import · Class 1 Selatogrel注射液 · No verified English nameJXHL2200162 Idorsia Pharmaceuticals Ltd; Idorsia (Beijing) Pharmaceuticals Co. Ltd
2022/06/28Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2200965 Beijing Fu Kang Ren Biopharmaceutical Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized

39 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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