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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 280 drug applications between 12 August 2022 and 18 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 31 drug names.

2022/08/12 – 2022/08/18

Period
2022/08/12 to 2022/08/18, 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
280
Drugs with new generic filings (by drug name, de-duplicated)
31
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

280filings, 46 of them generic

By application type

Application typeFilings
Supplement159
Generic46
New drug26
Import23
Import re-registration21
Unspecified5

By drug type

Drug typeFilings
Chemical drug197
Therapeutic biologic40
TCM38
Biologic2
Prophylactic 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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1泊马度胺胶囊 · No verified English name414
2Midazolam Injection310
3Piperacillin Sodium And Tazobactam Sodium For Injection315
4Sitagliptin Phosphate Tablets312
5Gadopentetic Acid Dimeglumine Salt Injection319
6Acetylcysteine Solution For Inhalation224
7Sevelamer Carbonate Powder for oral suspension213
8Minoxidil Liniment2152
9Calcium Gluconate in Sodium Chloride Injection215
10Folic Acid Tablets1112

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

157 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized15150
2Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized10100
3Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized947
4Roche Pharma (Schweiz) AG620
5Qilu Pharmaceutical Co., Ltd.624
6Beijing Xiang Rui Bio Zhi Pin Co., Ltd. romanized520
7Bristol-Myers Squibb Pharma EEIG510
8Beijing Yu Sheng Tang Group Shijiazhuang Pharmaceutical Co., Ltd. romanized440
9Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized440
10Merck Sharp & Dohme B.V.420

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

61 this week

AcceptedDrugApplicants
2022/08/18Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSS2200033 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2022/08/18Import · Class 2.2 注射用维得利珠单抗 · No verified English nameJXSL2200137 Takeda Development Center Americas Inc.
2022/08/18Import · Class 2.2 注射用维得利珠单抗 · No verified English nameJXSL2200136 Takeda Development Center Americas Inc.
2022/08/18Import · Class 2.2 Tezepelumab注射液 · No verified English nameJXSL2200135 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2022/08/18Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2200247 AbbVie Inc.
2022/08/18Generic · Class 3 Nicorandil for InjectionCYHS2201328 Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Hebei Ai Er Hai Tai Pharmaceutical Co., Ltd. romanized
2022/08/18Generic · Class 3 Metaraminol Tartrate InjectionCYHS2201327 Topfond Pharmaceutical Co., Ltd.
2022/08/18New drug · Class 1.2 荔枝核提取物 · No verified English nameCXZL2200040 Guangxi Zhong Pharmaceuticals University romanized
2022/08/18New drug · Class 1.2 荔枝核胶囊 · No verified English nameCXZL2200039 Guangxi Zhong Pharmaceuticals University romanized
2022/08/18New drug · Class 2.4 Folic Acid TabletsCXHL2200594 Beijing Si Li An Pharma Co., Ltd. romanized
2022/08/18New drug · Class 1 TB-D004C注射液 · No verified English nameCXHL2200593 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2022/08/18New drug · Class 1 TB-D004C注射液 · No verified English nameCXHL2200592 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2022/08/17Generic · Class 3 Folic Acid TabletsCYHS2201324 Beijing Si Li An Pharma Co., Ltd. romanized
2022/08/17Generic · Class 3 Hydrotalcite SuspensionCYHS2201322 Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/17Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201321 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/08/17Generic · Class 3 Azilsartan and Amlodipine TabletsCYHL2200066 Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2022/08/17New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2200379 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2022/08/17New drug · Class 2.2 卡托普利口服溶液 · No verified English nameCXHL2200591 Sichuan Bai Li Pharma Co., Ltd. romanized
2022/08/16Import · Class 1 STN1013400滴眼液 · No verified English nameJXHL2200243 Santen Pharmaceutical Co. Ltd.
2022/08/16Import · Class 1 STN1013400滴眼液 · No verified English nameJXHL2200242 Santen Pharmaceutical Co. Ltd.
2022/08/16Import · Class 1 STN1013400滴眼液 · No verified English nameJXHL2200241 Santen Pharmaceutical Co. Ltd.
2022/08/16Import · Class 1 INCB000928片 · No verified English nameJXHL2200240 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2022/08/16Generic · Class 3 Minoxidil LinimentCYHS2201319 Anhui Pioneer Pharmaceutical Co., Ltd
2022/08/16Generic · Class 3 Minoxidil LinimentCYHS2201318 Anhui Pioneer Pharmaceutical Co., Ltd
2022/08/16Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2201313 Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/08/16Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2201312 Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201310 Qilu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201308 Qilu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201307 Qilu Pharmaceutical Co., Ltd.
2022/08/16Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHS2201306 Qilu Pharmaceutical Co., Ltd.

31 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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