YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 172 drug applications between 5 March 2021 and 11 March 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 14 drug names.

2021/03/05 – 2021/03/11

Period
2021/03/05 to 2021/03/11, 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
172
Drugs with new generic filings (by drug name, de-duplicated)
14
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

172filings, 24 of them generic

By application type

Application typeFilings
Supplement92
Generic24
New drug22
Import17
Import re-registration11
Unspecified6

By drug type

Drug typeFilings
Chemical drug113
Therapeutic biologic31
TCM22
Prophylactic biologic3
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

14 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
6Atomoxetine Hydrochloride Capsules216
7Esomeprazole Magnesium Enteric-Coated Capsules214
8Tadalafil Tablets1123
9Tofacitinib Citrate Tablets111
10Parecoxib Sodium for Injection112

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

100 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized850
2Fresenius Kabi Austria GmbH720
3Gansu Qi Zheng Zang Yao Co., Ltd. romanized660
4Astrazeneca UK Limited610
5Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized520
6Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized420
7Chiesi Farmaceutici S.p.A.330
8Chengdu Brilliant Pharmaceutical Co., Ltd.320
9CISEN PHARMACEUTICAL CO., LTD.321
10Sanofi-Aventis Deutschland GmbH310

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

46 this week

AcceptedDrugApplicants
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
2021/03/10Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2100270 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/03/10Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2100269 Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2021/03/10Generic · Class 3 二甲磺酸赖右苯丙胺胶囊 · No verified English nameCYHL2100016 Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized
2021/03/10Generic · Class 3 二甲磺酸赖右苯丙胺胶囊 · No verified English nameCYHL2100015 Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized
2021/03/10Generic · Class 3 二甲磺酸赖右苯丙胺胶囊 · No verified English nameCYHL2100014 Jiangsu Hua Tai Chen Guang Pharma Co., Ltd. romanized
2021/03/10New drug · Class 1.1 苏夏解郁除烦胶囊 · No verified English nameCXZS2100007 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2021/03/10New drug · Class 1 SHR-1905注射液 · No verified English nameCXSL2100088 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/03/10New drug · Class 1 重组柯萨奇病毒B3注射剂 · No verified English nameCXSL2100087 Wuhan Bo Wei De Bio Technology Co., Ltd. romanized
2021/03/10New drug · Class 1 TT-00420片 · No verified English nameCXHL2100179 Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized
2021/03/10New drug · Class 1 TT-00420片 · No verified English nameCXHL2100178 Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized
2021/03/10New drug · Class 1 TT-00420片 · No verified English nameCXHL2100177 Nanjing Yao Jie An Kang Bio Technology Co., Ltd. romanized
2021/03/10New drug · Class 1 SYHA1811片 · No verified English nameCXHL2100171 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2021/03/09Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100264 Chongqing Lai Mei Pharma Co., Ltd. romanized
2021/03/09Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2100263 Chongqing Lai Mei Pharma Co., Ltd. romanized
2021/03/09New drug · Class 2.2 重组抗EGFR人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2100086 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/03/09New drug · Class 3.3 水痘减毒活疫苗 · No verified English nameCXSL2100085 Ke Xing (Da Lian) Yi Miao Technology Co., Ltd. romanized

16 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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