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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 214 drug applications between 12 February 2022 and 18 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 36 drug names.

2022/02/12 – 2022/02/18

Period
2022/02/12 to 2022/02/18, 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
214
Drugs with new generic filings (by drug name, de-duplicated)
36
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

214filings, 48 of them generic

By application type

Application typeFilings
Supplement114
Generic48
New drug31
Unspecified11
Import10

By drug type

Drug typeFilings
Chemical drug153
Therapeutic biologic34
TCM26
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

36 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
2Regorafenib Tablets223
3Cinacalcet Hydrochloride Tablets222
4Nintedanib Esilate Soft Capsules216
5利奈唑胺干混悬剂 · No verified English name211
6注射用头孢西丁钠/氯化钠注射液 · No verified English name210
7Metoprolol Succinate Sustained-release Tablets214
8Memantine Hydrochloride Tablets212
9Eldecalcitol Soft Capsules218
10Febuxostat Tablets2112

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

128 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Zhuang Zu Zi Zhi Qu Hua Hong Jin Rui Pharma Co., Ltd. romanized1080
2Sanofi-Aventis Deutschland GmbH660
3AstraZeneca UK Limited620
4Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized550
5Changchun Jin Sai Pharma Co., Ltd. romanized510
6Rui Yang Pharmaceutical Co., Ltd. romanized420
7Alembic Pharmaceuticals Limited410
8Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized410
9Changzhou Pharmaceutical Factory Co., Ltd. romanized414
10Jiangsu Kang Yuan Pharma Co., Ltd. romanized330

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

48 this week

AcceptedDrugApplicants
2022/02/18Import · Class 1 Olvi-Vec注射液 · No verified English nameJXSL2200020 Genelux Corporation; Newsoara Biopharma Co. Ltd.
2022/02/18Generic · Class 3 Terbutaline Sulfate InjectionCYHS2200341 Chengdu Li Er Pharma Co., Ltd. romanized
2022/02/18Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHL2200021 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2022/02/18Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHL2200020 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2022/02/18Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHL2200019 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2022/02/18Generic · Class 3 泊马度胺胶囊 · No verified English nameCYHL2200018 Changzhou Pharmaceutical Factory Co., Ltd. romanized
2022/02/18New drug · Class 2.3 苁蓉总苷胶囊 · No verified English nameCXZL2200011 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/02/18New drug · Class 3.4 注射用重组人凝血因子Ⅷ · No verified English nameCXSS2200014 Chengdu Rong Sheng Pharma Co., Ltd. romanized
2022/02/18New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200098 Shanghai Ai Sa Er Bio Technology Co., Ltd. romanized
2022/02/18New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2200097 Shanghai Ai Sa Er Bio Technology Co., Ltd. romanized
2022/02/18New drug · Class 1 SHR-2010 注射液 · No verified English nameCXSL2200096 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/02/18New drug · Class 1 HS-10384片 · No verified English nameCXHL2200102 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/18New drug · Class 1 HS-10384片 · No verified English nameCXHL2200101 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/18New drug · Class 2.1 注射用HR1801 · No verified English nameCXHL2200100 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized
2022/02/17Import · Class 1 Olvi-Vec注射液 · No verified English nameJXSL2200019 Genelux Corporation; Newsoara Biopharma Co. Ltd.
2022/02/17Import · Class 2.2 注射用Belantamab mafodotin · No verified English nameJXSL2200018 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Co. Limited
2022/02/17Generic · Class 3 注射用头孢西丁钠/氯化钠注射液 · No verified English nameCYHS2200336 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2022/02/17Generic · Class 3 注射用头孢西丁钠/氯化钠注射液 · No verified English nameCYHS2200335 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2022/02/17Generic · Class 3 Calcium Polycarbophil Fine GranulesCYHS2200334 Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized
2022/02/17Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2200329 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2022/02/17Generic · Class 3 Citicoline Sodium InjectionCYHS2200323 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/02/17New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2200015 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/02/17New drug · Class 1 DB-1202注射液 · No verified English nameCXSL2200095 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/02/17New drug · Class 1 PM8002注射液 · No verified English nameCXSL2200094 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/02/17New drug · Class 1 R01散 · No verified English nameCXHL2200099 Beijing An Jian Xi Pharmaceuticals Technology Co., Ltd. romanized
2022/02/17New drug · Class 1 TT-01488片 · No verified English nameCXHL2200092 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2022/02/16New drug · Class 2.3 大株红景天胶囊 · No verified English nameCXZL2200010 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/02/16New drug · Class 1 EVER001胶囊 · No verified English nameCXHL2200098 Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized
2022/02/16New drug · Class 1 SR750片 · No verified English nameCXHL2200095 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2022/02/16New drug · Class 1 SR750片 · No verified English nameCXHL2200094 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized

18 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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