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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 390 drug applications between 1 February 2023 and 7 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 123, covering 86 drug names.

2023/02/01 – 2023/02/07

Period
2023/02/01 to 2023/02/07, 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
390
Drugs with new generic filings (by drug name, de-duplicated)
86
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

390filings, 123 of them generic

By application type

Application typeFilings
Supplement164
Generic123
New drug64
Import16
Import re-registration14
Unspecified9

By drug type

Drug typeFilings
Chemical drug301
Therapeutic biologic47
TCM40
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

86 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution5223
2Lactulose Oral Solution4234
3Phenylephrine Hydrochloride Injection425
4Minoxidil Topical Solution420
5Calcium Levofolinate Injection410
6Phloroglucinol Injection332
7Peramivir Injection327
8Amoxicillin Sodium for Injection310
9Indobufen Tablets226
10Mecobalamin Tablets2216

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

237 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ping Guang Pharmaceutical Co., Ltd. romanized13120
2Anhui Pioneer Pharmaceutical Co., Ltd930
3Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized720
4Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized666
5Hunan Ke Lun Pharmaceutical Co., Ltd. romanized644
6Qilu Pharmaceutical Co., Ltd.631
7Bracco Imaging Italia s.r.l.610
8Sichuan Kelun Pharmaceutical Co., Ltd.541
9Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
10Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized434

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

130 this week

AcceptedDrugApplicants
2023/02/07Import · Class 2.2 索安非托片 · No verified English nameJXHL2300020 Axsome Malta Ltd.; Ignis Therapeutics (Suzhou) Limited
2023/02/07Generic · Class 3 Trimebutine Maleate TabletsCYHS2300384 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300383 Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300382 Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Potassium Aspartate InjectionCYHS2300373 Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2023/02/07Generic · Class 3 Methocarbamol InjectionCYHS2300368 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/02/07Generic · Class 3 Penicillin G Sodium For InjectionCYHS2300364 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2023/02/07New drug · Class 3.3 托珠单抗注射液 · No verified English nameCXSS2300005 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized
2023/02/07New drug · Class 1 CAStem细胞注射液 · No verified English nameCXSL2300091 Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized
2023/02/07New drug · Class 1 Y332 · No verified English nameCXSL2300090 Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized
2023/02/07New drug · Class 1 Y400 · No verified English nameCXSL2300089 Shenzhen Shi Kang Zhe Wei Sheng Pharmaceuticals Development Co., Ltd. romanized
2023/02/07New drug · Class 2.2 纳曲酮植入剂 · No verified English nameCXHS2300025 Shenzhen Shan Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/02/07New drug · Class 2.2 盐酸曲美他嗪多释片 · No verified English nameCXHL2300176 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2023/02/07New drug · Class 2.4 注射用紫杉醇聚合物胶束 · No verified English nameCXHL2300175 Shanghai Yi Zhong Pharma Co., Ltd. romanized
2023/02/07New drug · Class 1 SY-5933片 · No verified English nameCXHL2300174 Shou Yao Holding (Beijing) Co., Ltd. romanized
2023/02/07New drug · Class 1 注射用JJH201601脂质体 · No verified English nameCXHL2300173 Jiangsu Ji Bei Er Pharma Co., Ltd. romanized
2023/02/06Generic · Class 3 Indobufen TabletsCYHS2300362 Chengdu Shuo De Pharma Co., Ltd. romanized
2023/02/06Generic · Class 3 Furosemide InjectionCYHS2300361 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/02/06Generic · Class 3 Furosemide InjectionCYHS2300360 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
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

100 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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