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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 405 drug applications between 16 May 2023 and 22 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 44 drug names.

2023/05/16 – 2023/05/22

Period
2023/05/16 to 2023/05/22, 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
405
Drugs with new generic filings (by drug name, de-duplicated)
44
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

405filings, 59 of them generic

By application type

Application typeFilings
Supplement237
New drug68
Generic59
Import18
Import re-registration14
Unspecified9

By drug type

Drug typeFilings
Chemical drug254
TCM101
Therapeutic biologic45
Biologic3
Prophylactic 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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets4112
2Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets310
3Indobufen Tablets226
4Sodium Hyaluronate Eye Drops2230
5腺苷钴胺胶囊 · No verified English name228
6Isoprenaline Hydrochloride Injection217
7Naloxone Hydrochloride Injection211
8Dapoxetine Hydrochloride Tablets2120
9硫酸特布他林口服溶液 · No verified English name214
10Roxadustat Capsules2117

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

184 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized76740
2Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized24120
3Hubei Lang De Pharma Co., Ltd. romanized20100
4Ping Guang Pharmaceutical Co., Ltd. romanized14140
5AbbVie Inc.620
6UCB Pharma SA610
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
9Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized414
10Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized410

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

112 this week

AcceptedDrugApplicants
2023/05/22Import · Class 1 SAR442501 · No verified English nameJXSL2300097 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2023/05/22Generic · Class 3 Lincomycin InjectionCYHS2301368 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/05/22Generic · Class 3 Biapenem For InjectionCYHS2301365 Anhui Pioneer Pharmaceutical Co., Ltd
2023/05/22Generic · Class 3 Methotrexate TabletsCYHS2301363 Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized
2023/05/22Generic · Class 3 Pentazocine InjectionCYHS2301361 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/05/22New drug · Class 1 注射用XNW28012 · No verified English nameCXSL2300365 Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized
2023/05/22New drug · Class 1 SM17单克隆抗体注射液 · No verified English nameCXSL2300364 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2023/05/22New drug · Class 1 ONC-392注射液 · No verified English nameCXSL2300363 Guangzhou Ang Ke Mian Yi Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300362 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300361 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 1 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300360 Shanghai Xian Bo Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 1 TQ-B3525片 · No verified English nameCXHS2300050 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/05/22New drug · Class 1 XYD-A01 · No verified English nameCXHL2300555 Kun Shan Xin Yun Da Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 1 BGB-24714胶囊 · No verified English nameCXHL2300554 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 1 BGB-24714胶囊 · No verified English nameCXHL2300553 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 1 BGB-24714胶囊 · No verified English nameCXHL2300552 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2023/05/22New drug · Class 2.1 SF001 · No verified English nameCXHL2300551 Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized
2023/05/22New drug · Class 2.1 SF001 · No verified English nameCXHL2300550 Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized
2023/05/22New drug · Class 2.1 SF001 · No verified English nameCXHL2300549 Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized
2023/05/22New drug · Class 1 YL-17231片 · No verified English nameCXHL2300548 Shanghai Ying Li Pharma Co., Ltd. romanized
2023/05/22New drug · Class 1 YL-17231片 · No verified English nameCXHL2300547 Shanghai Ying Li Pharma Co., Ltd. romanized
2023/05/22New drug · Class 1 YL-17231片 · No verified English nameCXHL2300546 Shanghai Ying Li Pharma Co., Ltd. romanized
2023/05/22New drug · Class 1 ASP3082注射液 · No verified English nameCXHL2300545 An Si Tai Lai (Zhongguo) Investment Co., Ltd. romanized
2023/05/22New drug · Class 1 APG-2449胶囊 · No verified English nameCXHL2300544 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2023/05/22New drug · Class 1 DF-006 · No verified English nameCXHL2300543 Zhejiang Yao Yuan Bio Technology Co., Ltd. romanized
2023/05/19Import · Class 1 Cenerimod片 · No verified English nameJXHL2300122 Idorsia Pharmaceuticals Ltd; Idorsia (Beijing) Pharmaceuticals Co. Ltd
2023/05/19Import · Class 1 Aficamten片 · No verified English nameJXHL2300121 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/05/19Import · Class 1 Aficamten片 · No verified English nameJXHL2300120 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2023/05/19Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301360 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/05/19Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301359 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized

82 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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