YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 151 drug applications between 12 March 2021 and 18 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 26, covering 18 drug names.

2021/03/12 – 2021/03/18

Period
2021/03/12 to 2021/03/18, 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
151
Drugs with new generic filings (by drug name, de-duplicated)
18
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

151filings, 26 of them generic

By application type

Application typeFilings
Supplement71
Generic26
New drug22
Unspecified14
Import re-registration11
Import7

By drug type

Drug typeFilings
Chemical drug115
Therapeutic biologic17
TCM11
Prophylactic biologic6
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Valproate Concentrated Solution for Injection310
2Brexpiprazole Tablets3131
3Pemetrexed Disodium for Injection214
4盐酸溴己新颗粒 · No verified English name210
5Cinacalcet Hydrochloride Tablets212
6Febuxostat Tablets2112
7Tadalafil Tablets1123
8Ambroxol Hydrochloride Solution For Inhalation1110
9Lacosamide Oral Solution110
10氯化钾缓释片(I) · 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

103 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized950
2Boehringer Ingelheim International GmbH610
3Pfizer Healthcare Ireland410
4Santen Pharmaceutical Co. Ltd.410
5Daiichi Sankyo Europe GmbH310
6Sichuan Qi Li Pharmaceutical Co., Ltd. romanized310
7Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized313
8YaoPharma Co., Ltd.313
9Novartis Europharm Limited220
10Name not romanized220

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

36 this week

AcceptedDrugApplicants
2021/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101023 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101022 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2101021 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/03/18New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2101005 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2021/03/18New drug · Class 1 HTD1801胶囊 · No verified English nameCXHL2100190 Shenzhen Jun Sheng Tai Bio Technology Co., Ltd. romanized
2021/03/17Generic · Class 3 Lormetazepam InjectionCYHL2100017 Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized
2021/03/17New drug · Class 1 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2101004 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2021/03/17New drug · Class 1 阴道用四联乳杆菌活菌胶囊 · No verified English nameCXSL2101003 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2021/03/17New drug · Class 1 ASC42片 · No verified English nameCXHL2101004 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/03/17New drug · Class 1 ASC42片 · No verified English nameCXHL2101003 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/03/16Generic · Class 3 氯化钾缓释片(I) · No verified English nameCYHS2100285 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2021/03/16Generic · Class 3 Brexpiprazole TabletsCYHS2100283 YaoPharma Co., Ltd.
2021/03/16Generic · Class 3 Brexpiprazole TabletsCYHS2100282 YaoPharma Co., Ltd.
2021/03/16Generic · Class 3 Brexpiprazole TabletsCYHS2100281 YaoPharma Co., Ltd.
2021/03/16Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2100280 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2021/03/16New drug · Class 1 BGB-A1217 注射液 · No verified English nameCXSL2100096 Bai Ji Shen Zhou (Guangzhou) Bio Technology Co., Ltd. romanized
2021/03/16New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2100189 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2021/03/16New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2100188 Guangzhou Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2021/03/16New drug · Class 1 EY-1936注射液 · No verified English nameCXHL2100185 Suzhou Erye Pharmaceutical Co., Ltd
2021/03/16New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2100184 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2021/03/12Import · Class 1 Berzosertib注射液 · No verified English nameJXHL2100087 Merck Healthcare KGaA
2021/03/12Generic · Class 3 Amphotericin B Liposome for InjectionCYHS2101018 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2021/03/12Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2100278 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2021/03/12Generic · Class 3 盐酸溴己新颗粒 · No verified English nameCYHS2100274 Jiangxi Yi You Pharma Co., Ltd. romanized
2021/03/12Generic · Class 3 盐酸溴己新颗粒 · No verified English nameCYHS2100273 Jiangxi Yi You Pharma Co., Ltd. romanized
2021/03/12New drug · Class 1 AK104注射液 · No verified English nameCXSL2100095 Kang Fang Pharma Co., Ltd. romanized
2021/03/12New drug · Class 1 AK109注射液 · No verified English nameCXSL2100094 Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2021/03/12New drug · Class 1 AK112注射液 · No verified English nameCXSL2100093 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/03/12New drug · Class 2.2 康柏西普眼用注射液 · No verified English nameCXSL2100092 Chengdu Kang Hong Bio Technology Co., Ltd. romanized
2021/03/12New drug · Class 1 REGEND001细胞自体回输制剂 · No verified English nameCXSL2100091 Jiangxi Sheng Xian He Yi Xue Technology Co., Ltd. romanized

6 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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