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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 380 drug applications between 11 May 2023 and 17 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 51 drug names.

2023/05/11 – 2023/05/17

Period
2023/05/11 to 2023/05/17, 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
380
Drugs with new generic filings (by drug name, de-duplicated)
51
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

380filings, 72 of them generic

By application type

Application typeFilings
Supplement222
Generic72
New drug52
Import17
Import re-registration11
Unspecified6

By drug type

Drug typeFilings
Chemical drug216
TCM122
Therapeutic biologic40
Biologic2

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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets4112
2硝普钠氯化钠注射液 · No verified English name413
3Famotidine Injection338
4吸入用七氟烷 · No verified English name310
5Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets310
6腺苷钴胺胶囊 · No verified English name228
7Ipratropium Bromide Inhalation Solution212
8Vonoprazan Fumarate Tablets2160
9Quetiapine Fumarate Extended-release Tablets210
10Tirofiban Hydrochloride And Sodium Chloride Injection212

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

189 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized43340
2Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized39380
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized15140
4AbbVie Inc.620
5Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
6Bright Future Pharmaceuticals Factory540
7Anhui Hai Shen Shou Chun Pharma Co., Ltd. romanized440
8Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized420
9Hubei Lang De Pharma Co., Ltd. romanized420
10Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized414

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

97 this week

AcceptedDrugApplicants
2023/05/17Import · Class 1 JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2300095 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/05/17Import · Class 1 JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2300094 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/05/17Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301339 Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2023/05/17Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301338 Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2023/05/17Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301337 Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2023/05/17Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301336 Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2023/05/17Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2301335 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/05/17Generic · Class 3 Pregabalin Oral SolutionCYHS2301334 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2023/05/17Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2301332 Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized
2023/05/17Generic · Class 3 Cycloserine CapsulesCYHS2301331 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/05/17Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2301329 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized
2023/05/17Generic · Class 3 Nicorandil for InjectionCYHS2301328 Chongqing De Cheng Yong Dao Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd.
2023/05/17Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2301327 Chengdu Li Er Pharma Co., Ltd. romanized
2023/05/17Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2301326 Chengdu Li Er Pharma Co., Ltd. romanized
2023/05/17Generic · Class 3 Progesterone InjectionCYHS2301325 Beijing Pin Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/05/17Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2301324 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/05/17New drug · Class 1 TQH2722注射液 · No verified English nameCXSL2300348 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/05/17New drug · Class 1 BBM-H803注射液 · No verified English nameCXSL2300347 Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized
2023/05/17New drug · Class 1 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2300346 Wuhan Rui Jian Pharmaceuticals Technology Co., Ltd. romanized
2023/05/17New drug · Class 2.2 培集成干扰素α-2注射液 · No verified English nameCXSL2300345 Beijing Kai Yin Technology Co., Ltd. romanized
2023/05/17New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2300533 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/05/17New drug · Class 1 BGB-11417薄膜包衣片 · No verified English nameCXHL2300532 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/05/17New drug · Class 1 LL-50注射液 · No verified English nameCXHL2300531 Sichuan University Hua Xi Hospital romanized; Yi Chang Ren Fu Pharma Co., Ltd. romanized
2023/05/17New drug · Class 1 RG003片 · No verified English nameCXHL2300530 Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized
2023/05/17New drug · Class 1 RG003片 · No verified English nameCXHL2300529 Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized
2023/05/17New drug · Class 1 RG003片 · No verified English nameCXHL2300528 Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized
2023/05/16Import · Class 2.2 Glofitamab注射液 · No verified English nameJXSL2300093 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/05/16Import · Class 1 CC-99282胶囊 · No verified English nameJXHL2300117 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/05/16Import · Class 2.4 Infigratinib胶囊 · No verified English nameJXHL2300116 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/05/16Import · Class 2.4 Infigratinib胶囊 · No verified English nameJXHL2300115 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.

67 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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