YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 280 drug applications between 13 August 2022 and 19 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 39 drug names.

2022/08/13 – 2022/08/19

Period
2022/08/13 to 2022/08/19, 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)
39
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, 56 of them generic

By application type

Application typeFilings
Supplement149
Generic56
New drug28
Import19
Import re-registration19
Unspecified9

By drug type

Drug typeFilings
Chemical drug200
TCM39
Therapeutic biologic37
Biologic2
In vitro diagnostic reagent1
Prophylactic biologic1

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

39 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
2Sodium Bicarbonate Ringer’s Injection321
3Oseltamivir Phosphate Capsules3139
4Sitagliptin Phosphate Tablets312
5Gadopentetic Acid Dimeglumine Salt Injection319
6Acetylcysteine Solution For Inhalation224
7Peramivir Injection227
8Tadalafil Tablets2123
9Sevelamer Carbonate Powder for oral suspension213
10Minoxidil Liniment2152

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

166 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
3Qilu Pharmaceutical Co., Ltd.624
4Beijing Xiang Rui Bio Zhi Pin Co., Ltd. romanized520
5Bristol-Myers Squibb Pharma EEIG510
6Beijing Yu Sheng Tang Group Shijiazhuang Pharmaceutical Co., Ltd. romanized440
7Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized440
8Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.440
9Merck Sharp & Dohme B.V.420
10Shandong Qidu Pharmaceutical Co., Ltd.424

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

65 this week

AcceptedDrugApplicants
2022/08/19Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201348 Shandong Qidu Pharmaceutical Co., Ltd.
2022/08/19Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201347 Shandong Qidu Pharmaceutical Co., Ltd.
2022/08/19Generic · Class 3 Peramivir InjectionCYHS2201341 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2022/08/19Generic · Class 3 Gallium[68Ga ] Dotatate InjectionCYHL2200068 Yuan Zi Gao Ke Co., Ltd. romanized
2022/08/19Generic · Class 3 Kit For The Preparation Of Gallium Ga 68 Dotatate InjectionCYHL2200067 Yuan Zi Gao Ke Co., Ltd. romanized
2022/08/19New drug · Class 3.3 注射用重组人促卵泡激素 · No verified English nameCXSL2200384 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2022/08/19New drug · Class 2.1 人干扰素α1b吸入溶液 · No verified English nameCXSL2200383 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2022/08/19New drug · Class 2.1 人干扰素α1b吸入溶液 · No verified English nameCXSL2200382 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2022/08/19New drug · Class 1 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788) · No verified English nameCXSL2200381 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2022/08/19New drug · Class 1 STC007注射液 · No verified English nameCXHL2200599 Chengdu Nuo He Cheng Tai Bio Technology Co., Ltd. romanized
2022/08/19New drug · Class 1 JAB-2485片 · No verified English nameCXHL2200598 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2022/08/19New drug · Class 1 JAB-2485片 · No verified English nameCXHL2200597 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2022/08/19New drug · Class 1 FC084CSA片 · No verified English nameCXHL2200596 Zhong Shan Yi Nuo Wei Shen Xin Yao Research and Development Co., Ltd. romanized
2022/08/19New drug · Class 1 FC084CSA片 · No verified English nameCXHL2200595 Zhong Shan Yi Nuo Wei Shen Xin Yao Research and Development Co., Ltd. romanized
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

35 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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