YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 282 drug applications between 8 August 2021 and 14 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 33 drug names.

2021/08/08 – 2021/08/14

Period
2021/08/08 to 2021/08/14, 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
282
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
1

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

282filings, 44 of them generic

By application type

Application typeFilings
Supplement124
New drug62
Generic44
Unspecified27
Import17
Import re-registration8

By drug type

Drug typeFilings
Chemical drug205
Therapeutic biologic54
TCM22
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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pregabalin Capsules3112
2Meropenem for Injection315
3Omeprazole and Sodium Bicarbonate Capsules210
4Torsemide Injection211
5Gemcitabine Hydrochloride for Injection211
6Irinotecan Hydrochloride Injection212
7Vardenafil Hydrochloride Tablets214
8硫酸沙丁胺醇吸入溶液 · No verified English name210
9草酸艾司西酞普兰口服溶液 · No verified English name2111
10丙酸氟替卡松吸入粉雾剂 · No verified English name111

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

156 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Er Ye Pharmaceutical Co., Ltd. romanized1130
2Novartis Pharma Schweiz AG930
3AstraZeneca AB830
4Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized830
5Oncotec Pharma Produktion GmbH810
6Eurofins Analytical Science Laboratories Inc.660
7Chengdu Rong Sheng Pharma Co., Ltd. romanized630
8Huang Shi Wei Sheng Cai Liao Pharma Co., Ltd. romanized550
9Janssen Research & Development LLC530
10Pfizer Europe MA EEIG520

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

95 this week

AcceptedDrugApplicants
2021/08/13Import · Class 2.2 DS-8201a · No verified English nameJXSL2101093 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/08/13Generic · Class 3 Pregabalin Oral SolutionCYHS2101579 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Nanjing Xing Yin Pharma Group Co., Ltd. romanized
2021/08/13Generic · Class 3 Calcitriol Oral SolutionCYHS2101575 Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized
2021/08/13New drug · Class 1 ADG126注射液 · No verified English nameCXSL2101263 Tian Yan Pharma (Suzhou) Co., Ltd. romanized
2021/08/13New drug · Class 1 重组人源化抗CD47单克隆抗体注射液 · No verified English nameCXSL2101262 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/08/13New drug · Class 1 ASC22注射液 · No verified English nameCXSL2101261 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2021/08/13New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101260 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/13New drug · Class 1 SHR8554注射液 · No verified English nameCXHL2101403 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/13New drug · Class 1 SHR8554注射液 · No verified English nameCXHL2101402 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/13New drug · Class 1 SHR0410注射液 · No verified English nameCXHL2101401 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/13New drug · Class 1 CGT-6321片 · No verified English nameCXHL2101400 Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2021/08/13New drug · Class 1 CGT-6321片 · No verified English nameCXHL2101399 Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2021/08/13New drug · Class 2.3 YK-1169 · No verified English nameCXHL2101398 Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized
2021/08/13New drug · Class 1 SHR2285片 · No verified English nameCXHL2101397 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/08/12Import · Class 1 Ziltivekimab 注射液 · No verified English nameJXSL2101092 Novo Nordisk A/S; Novo Nordisk(China) Pharmaceuticals Co. Ltd
2021/08/12Import · Class 1 ricolinostat · No verified English nameJXHL2101163 Beijing B3R Pharmaceutical Technology HK Limited; PAREXEL CHINA CO. LTD
2021/08/12Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101565 Zhejiang Hua Yuan Pharma Co., Ltd. romanized
2021/08/12Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101564 Zhejiang Hua Yuan Pharma Co., Ltd. romanized
2021/08/12Generic · Class 3 Metronidazole and Sodium Chloride InjectionCYHS2101559 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2021/08/12New drug · Class 1 QX002N注射液 · No verified English nameCXSL2101259 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101258 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101257 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101256 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 GZR18 · No verified English nameCXSL2101255 Gan Li Pharma Co., Ltd. romanized
2021/08/12New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2101241 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/08/12New drug · Class 1 注射用HTPEP-001 · No verified English nameCXHL2101396 Chengdu Hui Tai Biopharmaceuticals Co., Ltd. romanized
2021/08/12New drug · Class 2.4; 2.2 BH011注射液 · No verified English nameCXHL2101395 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2021/08/11Import · Class 1 CC-99677胶囊 · No verified English nameJXHL2101162 Celgene Corporation; Name not romanized
2021/08/11Import · Class 1 CC-99677胶囊 · No verified English nameJXHL2101161 Celgene Corporation; Name not romanized
2021/08/11Generic · Class 3 Peramivir InjectionCYHS2101558 Yunnan Xian Shi Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.

65 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.

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.