YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 278 drug applications between 29 June 2022 and 5 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 33 drug names.

2022/06/29 – 2022/07/05

Period
2022/06/29 to 2022/07/05, 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
278
Drugs with new generic filings (by drug name, de-duplicated)
33
Accepted this week, now under review
2

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

278filings, 44 of them generic

By application type

Application typeFilings
Supplement129
New drug52
Generic44
Import25
Import re-registration25
Unspecified3

By drug type

Drug typeFilings
Chemical drug216
Therapeutic biologic37
TCM20
Prophylactic biologic5

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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Urapidil Hydrochloride Injection426
2Dapoxetine Hydrochloride Tablets3220
3Sodium Hyaluronate Eye Drops2230
4Indobufen Tablets216
5Levetiracetam extended-release tablets210
6Levofloxacin Injection211
7Paliperidone Extend-release Tablets212
8苯磺酸左氨氯地平片 · No verified English name2145
9Sodium Valproate Oral Solution111
10低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name114

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

158 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hebei Wu Luo Pharma Co., Ltd. romanized660
2Hubei Kang Wei Yuan Pharma Co., Ltd. romanized660
3Ren He Yi Kang Group Co., Ltd. romanized640
4AstraZeneca UK Limited620
5MUNDIPHARMA GmbH610
6Janssen Research & Development LLC540
7Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized420
8CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420
9Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized420
10Hunan Er Kang Pharmaceutical Co., Ltd. romanized420

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

77 this week

AcceptedDrugApplicants
2022/07/05Import · Class 1 RO6868847薄膜包衣片 · No verified English nameJXHL2200174 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/05Import · Class 1 RO6868847薄膜包衣片 · No verified English nameJXHL2200173 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/05Import · Class 2.2 TAR-200 · No verified English nameJXHL2200170 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/05Generic · Class 3 Indobufen TabletsCYHS2201013 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/07/05Generic · Class 3 Indobufen TabletsCYHS2201012 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/07/05Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2201004 Guangxi Jia Jin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/07/05New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200309 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/07/05New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200308 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/07/05New drug · Class 1 YZJ-4729酒石酸盐注射液 · No verified English nameCXHL2200482 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2022/07/05New drug · Class 1 IN10018片 · No verified English nameCXHL2200481 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2022/07/05New drug · Class 1 IN10018片 · No verified English nameCXHL2200480 Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized
2022/07/05New drug · Class 1 YZJ-5053片 · No verified English nameCXHL2200479 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2022/07/05New drug · Class 1 YZJ-5053片 · No verified English nameCXHL2200478 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2022/07/05New drug · Class 1 YZJ-5053片 · No verified English nameCXHL2200477 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2022/07/05New drug · Class 1 ENC0364 胶囊 · No verified English nameCXHL2200476 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized
2022/07/05New drug · Class 1 ENC0364 胶囊 · No verified English nameCXHL2200475 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized
2022/07/05New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200474 Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized
2022/07/05New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200473 Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized
2022/07/05New drug · Class 2.4 硫酸阿托品滴眼液 · No verified English nameCXHL2200472 Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized
2022/07/05New drug · Class 1 WJB001胶囊 · No verified English nameCXHL2200465 Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/07/05New drug · Class 1 WJB001胶囊 · No verified English nameCXHL2200464 Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/07/05New drug · Class 1 ENC0364 胶囊 · No verified English nameCXHL2200416 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized
2022/07/04Import · Class 1 Cetrelimab · No verified English nameJXSL2200102 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/04Import · Class 1 BN301 · No verified English nameJXSL2200101 Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/07/04Import · Class 1 BN301 · No verified English nameJXSL2200100 Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited
2022/07/04Import · Class 2.4 Upadacitinib片 · No verified English nameJXHL2200169 AbbVie Inc.
2022/07/04Generic · Class 3 Levetiracetam extended-release tabletsCYHS2200993 Hua Run Sai Ke Pharma Co., Ltd. romanized
2022/07/04Generic · Class 3 Levetiracetam extended-release tabletsCYHS2200992 Hua Run Sai Ke Pharma Co., Ltd. romanized
2022/07/04New drug · Class 1 AC-003胶囊 · No verified English nameCXHL2200471 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2022/07/04New drug · Class 1 AC-003胶囊 · No verified English nameCXHL2200470 Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized

47 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.