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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 355 drug applications between 12 May 2023 and 18 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 48 drug names.

2023/05/12 – 2023/05/18

Period
2023/05/12 to 2023/05/18, 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
355
Drugs with new generic filings (by drug name, de-duplicated)
48
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

355filings, 69 of them generic

By application type

Application typeFilings
Supplement202
Generic69
New drug52
Import18
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug204
TCM107
Therapeutic biologic41
Biologic2
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

48 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
3吸入用七氟烷 · No verified English name310
4Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets310
5Indobufen Tablets226
6腺苷钴胺胶囊 · No verified English name228
7Ipratropium Bromide Inhalation Solution212
8Quetiapine Fumarate Extended-release Tablets210
9Isoprenaline Hydrochloride Injection217
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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized51500
2An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized31240
3Ping Guang Pharmaceutical Co., Ltd. romanized14140
4AbbVie Inc.620
5Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized530
6Hubei Lang De Pharma Co., Ltd. romanized420
7Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized414
8Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized410
9Hainan Pu Li Pharmaceutical Co., Ltd. romanized414
10Bright Future Pharmaceuticals Factory330

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
2023/05/18Import · Class 1 BI 764532 输注用浓缩粉末 · No verified English nameJXSL2300096 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/05/18Generic · Class 3 Indobufen TabletsCYHS2301349 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Indobufen TabletsCYHS2301348 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/05/18Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2301346 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2301345 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Carbocisteine Oral SolutionCYHS2301344 Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Carbocisteine Oral SolutionCYHS2301343 Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/18Generic · Class 3 Amisulpride Oral SolutionCYHS2301342 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2023/05/18New drug · Class 3.2 尼妥珠单抗注射液 · No verified English nameCXSS2300035 Bai Tai Bio Pharma Co., Ltd. romanized
2023/05/18New drug · Class 1 注射用DR10624 · No verified English nameCXSL2300353 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2023/05/18New drug · Class 1 注射用DR10624 · No verified English nameCXSL2300352 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2023/05/18New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2300351 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2023/05/18New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2300350 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2023/05/18New drug · Class 2.4 Azacitidine For InjectionCXHL2300536 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/05/18New drug · Class 2.2 LPC-003口溶膜 · No verified English nameCXHL2300535 Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized
2023/05/18New drug · Class 1 HJ891胶囊 · No verified English nameCXHL2300534 Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized
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

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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