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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 498 drug applications between 29 January 2023 and 4 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 145, covering 103 drug names.

2023/01/29 – 2023/02/04

Period
2023/01/29 to 2023/02/04, 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
498
Drugs with new generic filings (by drug name, de-duplicated)
103
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

498filings, 145 of them generic

By application type

Application typeFilings
Supplement210
Generic145
New drug95
Import22
Import re-registration18
Unspecified8

By drug type

Drug typeFilings
Chemical drug399
Therapeutic biologic51
TCM44
Prophylactic biologic4

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

103 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution5323
2Lactulose Oral Solution4234
3Phenylephrine Hydrochloride Injection425
4Minoxidil Topical Solution420
5Calcium Levofolinate Injection410
6Famotidine Injection338
7Phloroglucinol Injection332
8Acetylcysteine Granules324
9Peramivir Injection327
10Amoxicillin Sodium for Injection310

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

288 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized13120
2Anhui Pioneer Pharmaceutical Co., Ltd930
3CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD830
4Shanghai Bo Lai Ke Xin Yi Pharma Co., Ltd. romanized810
5Yue Ming Tang (Shanxi) Zhong Yao Co., Ltd. romanized770
6Sichuan Kelun Pharmaceutical Co., Ltd.751
7Qilu Pharmaceutical Co., Ltd.741
8Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized720
9Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized666
10Bracco Imaging Italia s.r.l.610

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

175 this week

AcceptedDrugApplicants
2023/02/04Import · Class 3.1 尘螨变应原舌下片 · No verified English nameJXSS2300015 ALK-Abelló A/S; Catalent UK Swindon Zydis Limited
2023/02/04Import · Class 3.1 注射用tisotumab vedotin · No verified English nameJXSL2300032 Seagen Inc.; Zai Lab (Shanghai) CO. Ltd.
2023/02/04Import · Class 1 Milvexian片 · No verified English nameJXHL2300019 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/02/04Generic · Class 3 Mesalamine extended release capsulesCYHS2300356 Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized
2023/02/04Generic · Class 3 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2300355 Shandong Yi Kang Pharma Co., Ltd. romanized
2023/02/04Generic · Class 3 Oxaliplatin InjectionCYHS2300352 Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized
2023/02/04Generic · Class 3 Betahistine Dihydrochloride TabletsCYHS2300349 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Jinan Yong Ning Pharmaceutical Co., Ltd. romanized
2023/02/04Generic · Class 3 Famotidine InjectionCYHS2300342 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/02/04Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2300340 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/02/04Generic · Class 3 Metformin Hydrochloride Extended-release TabletsCYHS2300337 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2023/02/04Generic · Class 3 Calcium Levofolinate InjectionCYHS2300334 Zhejiang Pu Li Pharma Co., Ltd. romanized
2023/02/04Generic · Class 3 Calcium Levofolinate InjectionCYHS2300333 Zhejiang Pu Li Pharma Co., Ltd. romanized
2023/02/04Generic · Class 3 Calcium Levofolinate InjectionCYHS2300332 Zhejiang Pu Li Pharma Co., Ltd. romanized
2023/02/04Generic · Class 3 Calcium Levofolinate InjectionCYHS2300331 Zhejiang Pu Li Pharma Co., Ltd. romanized
2023/02/04New drug · Class 1 HG004眼用注射液 · No verified English nameCXSL2300088 Hui Da (Shanghai) Bio Technology Co., Ltd. romanized
2023/02/04New drug · Class 1 HG004眼用注射液 · No verified English nameCXSL2300087 Hui Da (Shanghai) Bio Technology Co., Ltd. romanized
2023/02/04New drug · Class 1 注射用XYD-9668-198抗体偶联剂 · No verified English nameCXSL2300086 Kun Shan Xin Yun Da Bio Technology Co., Ltd. romanized
2023/02/04New drug · Class 1 9MW2821 · No verified English nameCXSL2300085 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2023/02/04New drug · Class 1 SIM1811-03注射液 · No verified English nameCXSL2300084 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized
2023/02/04New drug · Class 1 TQB2450注射液 · No verified English nameCXSL2300083 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/02/04New drug · Class 1 注射用9MW2921 · No verified English nameCXSL2300082 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2023/02/04New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2300081 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/02/04New drug · Class 2.2 VGT-I01 · No verified English nameCXSL2300080 Shanghai Tian Ze Yun Tai Biopharmaceuticals Co., Ltd. romanized
2023/02/04New drug · Class 1 BD111注射液 · No verified English nameCXSL2300079 Shanghai Ben Dao Ji Yin Technology Co., Ltd. romanized
2023/02/04New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300172 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/02/04New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300171 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/02/04New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300170 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/02/04New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300169 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/02/04New drug · Class 1 TLL-018缓释片 · No verified English nameCXHL2300168 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2023/02/04New drug · Class 1 SHR0302口服溶液 · No verified English nameCXHL2300167 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

145 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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