YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 171 drug applications between 7 July 2022 and 13 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 26 drug names.

2022/07/07 – 2022/07/13

Period
2022/07/07 to 2022/07/13, 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
171
Drugs with new generic filings (by drug name, de-duplicated)
26
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

171filings, 35 of them generic

By application type

Application typeFilings
Supplement83
Generic35
Import21
New drug18
Import re-registration7
Unspecified6
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug125
Therapeutic biologic32
TCM10
Prophylactic biologic4

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Hydromorphone Hydrochloride Extended-Release Tablets310
2Aripiprazole Orally Disintegrating tablets311
3Phloroglucinol Injection222
4Ornidazole Injection210
5Escitalopram Oxalate Tablets216
6Calcium Gluconate in Sodium Chloride Injection215
7Ketorolac Tromethamine Injection214
8Canagliflozin Tablets118
9Diquafosol Sodium Eye Drops115
10孟鲁司特钠颗粒 · No verified English name110

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

109 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Actelion Pharmaceuticals Ltd810
2Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized720
3LES LABORATOIRES SERVIER530
4CSL Behring GmbH510
5Novo Nordisk A/S510
6Pfizer Europe MA EEIG430
7Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized332
8Grunenthal GmbH320
9Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.320
10NextWave Pharmaceuticals Inc a subsidiary of Tris Pharma Inc310

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

54 this week

AcceptedDrugApplicants
2022/07/12Import · Class 2.2 司美格鲁肽片 · No verified English nameJXSL2200108 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/07/12Import · Class 2.2 司美格鲁肽片 · No verified English nameJXSL2200107 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/07/12Import · Class 2.2 司美格鲁肽片 · No verified English nameJXSL2200106 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/07/12Import · Class 2.2 司美格鲁肽片 · No verified English nameJXSL2200105 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/07/12Import · Class 2.2 司美格鲁肽片 · No verified English nameJXSL2200104 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2022/07/12Import · Class 1 TAK-981 注射液 · No verified English nameJXHL2200179 Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd
2022/07/12Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2201007 YaoPharma Co., Ltd.
2022/07/12Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2201006 YaoPharma Co., Ltd.
2022/07/12Generic · Class 3 Aripiprazole Orally Disintegrating tabletsCYHS2201005 YaoPharma Co., Ltd.
2022/07/12New drug · Class 3.2 注射用重组替度鲁肽 · No verified English nameCXSL2200316 Chongqing Pai Jin Bio Technology Co., Ltd. romanized
2022/07/12New drug · Class 2.4 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2200497 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2022/07/12New drug · Class 1 XTN003098 · No verified English nameCXHL2200496 Shenzhen Zhong Ge Bio Technology Co., Ltd. romanized
2022/07/12New drug · Class 1 XTN003098 · No verified English nameCXHL2200495 Shenzhen Zhong Ge Bio Technology Co., Ltd. romanized
2022/07/12New drug · Class 1 STC007注射液 · No verified English nameCXHL2200494 Chengdu Nuo He Cheng Tai Bio Technology Co., Ltd. romanized
2022/07/12New drug · Class 1 EG017片 · No verified English nameCXHL2200493 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200118 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200117 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200116 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200115 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Import · Class 3.1 注射用重组人凝血因子IX-白蛋白融合蛋白 · No verified English nameJXSL2200114 CSL Behring GmbH; PAREXEL CHINA CO. LTD
2022/07/11Generic · Class 3 Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201047 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201046 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Hydromorphone Hydrochloride Extended-Release TabletsCYHS2201045 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Terlipressin Acetate InjectionCYHS2201042 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2022/07/11Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201041 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201040 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Florbetaben F-18 InjectionCYHS2201037 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Yuan Zi Gao Ke Tong Wei Su Pharmaceuticals Co., Ltd. romanized
2022/07/11Generic · Class 3 Mometasone Furoate CreamCYHS2201026 Fu Yuan Pharma Co., Ltd. romanized
2022/07/11Generic · Class 3 Pregabalin Extended release TabletsCYHL2200057 Qilu Pharmaceutical Co., Ltd.
2022/07/11Generic · Class 3 盐酸溴己新雾化吸入溶液 · No verified English nameCYHL2200056 Hainan Huluwa Pharmaceutical Group Co., Ltd.

24 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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