YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 221 drug applications between 6 March 2021 and 12 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 29, covering 18 drug names.

2021/03/06 – 2021/03/12

Period
2021/03/06 to 2021/03/12, 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
221
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

221filings, 29 of them generic

By application type

Application typeFilings
Supplement116
New drug30
Generic29
Import re-registration18
Import16
Unspecified12

By drug type

Drug typeFilings
Chemical drug153
Therapeutic biologic35
TCM23
Prophylactic biologic7
Biologic2
In vitro diagnostic reagent1

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
1Enzalutamide Soft Capsules332
2二甲磺酸赖右苯丙胺胶囊 · No verified English name310
3Levetiracetam in Sodium Chloride Injection312
4Levofloxacin Injection211
5Levofloxacin Tablets217
6盐酸溴己新颗粒 · No verified English name210
7Cinacalcet Hydrochloride Tablets212
8Esomeprazole Magnesium Enteric-Coated Capsules214
9Tadalafil Tablets1123
10Ambroxol Hydrochloride Solution For Inhalation1110

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

136 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized850
2Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized730
3Fresenius Kabi Austria GmbH720
4Gansu Qi Zheng Zang Yao Co., Ltd. romanized660
5Astrazeneca UK Limited610
6Boehringer Ingelheim International GmbH610
7Santen Pharmaceutical Co. Ltd.410
8Yue Kang Pharma Group Co., Ltd. romanized330
9SANOFI PASTEUR320
10CISEN PHARMACEUTICAL CO., LTD.321

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

53 this week

AcceptedDrugApplicants
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
2021/03/12New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSL2100090 Hebei Da An Pharmaceutical Co., Ltd. romanized
2021/03/12New drug · Class 1 TNM002注射液 · No verified English nameCXSL2100089 Zhuhai Tai Nuo Mai Bo Bio Technology Co., Ltd. romanized
2021/03/12New drug · Class 1 SHR3680片 · No verified English nameCXHL2100183 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/03/12New drug · Class 1 TT-00434片 · No verified English nameCXHL2100182 Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized
2021/03/12New drug · Class 1 TT-00434片 · No verified English nameCXHL2100181 Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized
2021/03/12New drug · Class 1 注射用MT1002 · No verified English nameCXHL2100180 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2021/03/11Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2100041 Merck Sharp & Dohme Corp.
2021/03/11Import · Class 1 KSI-301注射液 · No verified English nameJXSL2100040 Kodiak Sciences China Inc.
2021/03/11Import · Class 1 KSI-301注射液 · No verified English nameJXSL2100039 Kodiak Sciences China Inc.
2021/03/11Import · Class 1 IMSA101注射液 · No verified English nameJXHL2100084 ImmuneSensor Therapeutics Inc.
2021/03/11New drug · Class 1 TT-01025-CL片 · No verified English nameCXHL2100176 Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized
2021/03/11New drug · Class 1 TT-01025-CL片 · No verified English nameCXHL2100175 Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized
2021/03/11New drug · Class 1 ASC40片 · No verified English nameCXHL2100174 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/03/11New drug · Class 1 ASC40片 · No verified English nameCXHL2100173 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/03/11New drug · Class 1 ASC40片 · No verified English nameCXHL2100172 Gan Lai Pharmaceutical Co., Ltd. romanized
2021/03/10Import · Class 1 MK-7684A注射液 · No verified English nameJXSL2101001 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/03/10Import · Class 1 MK-7684A注射液 · No verified English nameJXSL2101000 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2021/03/10Import · Class 1 PF-07256472 · No verified English nameJXSL2100038 Pfizer Inc.
2021/03/10Import · Class 1 Xevinapant口服溶液 · No verified English nameJXHL2100083 Debiopharm International SA
2021/03/10Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2100271 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized

23 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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