YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 96 drug applications between 4 April 2022 and 10 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 19 drug names.

2022/04/04 – 2022/04/10

Period
2022/04/04 to 2022/04/10, 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
96
Drugs with new generic filings (by drug name, de-duplicated)
19
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

96filings, 25 of them generic

By application type

Application typeFilings
Supplement49
Generic25
New drug11
Import7
Unspecified3
Import re-registration1

By drug type

Drug typeFilings
Chemical drug76
Therapeutic biologic13
TCM5
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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cariprazine hydrochloride Capsules413
2Etoricoxib Tablets218
3Piracetam Injection219
4Ondansetron Hydrochloride Tablets216
5利奈唑胺氯化钠注射液 · No verified English name110
6Compound Ipratropium Bromide Solution For Inhalation114
7Ambroxol Hydrochloride Solution For Inhalation1110
8Salbutamol Sulfate Inhalation Solution112
9Acetaminophen Injection111
10Pentoxifylline Injection113

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

64 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Sheng Yi Feng Tang Technology Co., Ltd. romanized650
2Boehringer Ingelheim International GmbH510
3Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
4Novo Nordisk A/S410
5Chengdu Kang Hong Pharma Group Co., Ltd. romanized414
6Celgene International II Sarl310
7Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized310
8Clementia Pharmaceuticals Inc210
9N.V. Organon210
10Novartis Pharma Schweiz AG210

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

28 this week

AcceptedDrugApplicants
2022/04/08Import · Class 1 Donanemab注射液 · No verified English nameJXSL2200044 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/04/08Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2200547 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/08Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2200546 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/08Generic · Class 3 利奈唑胺氯化钠注射液 · No verified English nameCYHS2200543 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/08Generic · Class 3 瑞巴派特片 · No verified English nameCYHS2200541 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2022/04/08Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200031 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/04/08Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200030 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/04/08Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200029 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/04/08Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200028 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/04/08New drug · Class 1 AK112注射液 · No verified English nameCXSL2200163 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2022/04/08New drug · Class 1 人源脂肪间充质干细胞注射液 · No verified English nameCXSL2200162 Bo Pin Gu De Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/04/07Import · Class 3.1 Erenumab注射液 · No verified English nameJXSS2200012 Novartis Europharm Limited; Amgen Manufacturing Limited
2022/04/07Import · Class 1 BCX9930片 · No verified English nameJXHL2200083 BioCryst Pharmaceuticals Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2022/04/07Import · Class 1 注射用PEN-866钠 · No verified English nameJXHL2200082 Tarveda Therapeutics,Inc.; SciClone Pharmaceuticals (China) Co. Ltd.
2022/04/07Generic · Class 3 Piracetam InjectionCYHS2200540 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2022/04/07Generic · Class 3 Piracetam InjectionCYHS2200539 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2022/04/07Generic · Class 3 Acetaminophen InjectionCYHS2200533 Yi Chang Ren Fu Pharma Co., Ltd. romanized; Yi Chang San Xia Pharmaceutical Co., Ltd. romanized
2022/04/07Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2200530 Hubei Xing Hua Pharmaceutical Co., Ltd. romanized
2022/04/07New drug · Class 3.2 带状疱疹减毒活疫苗 · No verified English nameCXSS2200036 Changchun Bai Ke Bio Technology Shareholding Company romanized
2022/04/07New drug · Class 2.4 结核菌素纯蛋白衍生物 · No verified English nameCXSL2200161 Chengdu Ke En Bio Technology Co., Ltd. romanized
2022/04/07New drug · Class 2.2 氢氯噻嗪微片 · No verified English nameCXHL2200221 Beijing Ke Xin Bi Cheng Pharmaceuticals Technology Development Co., Ltd. romanized
2022/04/07New drug · Class 1 HH3806胶囊 · No verified English nameCXHL2200220 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2022/04/07New drug · Class 1 HH3806胶囊 · No verified English nameCXHL2200219 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2022/04/07New drug · Class 1 HH3806胶囊 · No verified English nameCXHL2200218 Shanghai Hai He Drug Research Kai Fa Co., Ltd. romanized
2022/04/07New drug · Class 2.2 PDX-03 · No verified English nameCXHL2200217 Hunan Jiudian Pharmaceutical Co., Ltd
2022/04/06Generic · Class 3 Pentoxifylline InjectionCYHS2200531 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2022/04/06New drug · Class 1.1 补髓益智颗粒 · No verified English nameCXZL2200017 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/04/06New drug · Class 1 注射用重组人IL-1RN-Fc融合蛋白 · No verified English nameCXSL2200160 Beijing Wei De Jie Bio Technology 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.