YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 396 drug applications between 11 May 2024 and 17 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 94, covering 67 drug names.

2024/05/11 – 2024/05/17

Period
2024/05/11 to 2024/05/17, 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
396
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
5

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

396filings, 94 of them generic

By application type

Application typeFilings
Supplement169
Generic94
New drug85
Import24
Import re-registration16
Unspecified5
Drug-device combination product3

By drug type

Drug typeFilings
Chemical drug276
Therapeutic biologic66
TCM44
Prophylactic biologic7
Drug-device combination3

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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets3260
2Sacubitril Valsartan Sodium Tablets3270
3Benidipine Hydrochloride Tablets324
4Sildenafil Citrate Tablets3112
5Nicorandil for Injection311
6Famotidine Injection228
7Phenylephrine Hydrochloride Injection225
8Glyburide and Metformin Hydrochloride Tablets210
9Tacrolimus Sustained-release Capsules216
10利伐沙班干混悬剂 · No verified English name212

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

222 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized17160
2Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized1020
3Yi Chang Ren Fu Pharma Co., Ltd. romanized720
4Pfizer Inc.630
5Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized610
6Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
7Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized545
8Hainan Huluwa Pharmaceutical Group Co., Ltd.535
9Janssen Research & Development LLC520
10NANJING ZENKOM PHARMACEUTICAL CO.,LTD.525

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

139 this week

AcceptedDrugApplicants
2024/05/17Import · Class 1 注射用M9140 · No verified English nameJXSL2400096 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2024/05/17Import · Class 2.2 Dostarlimab注射液 · No verified English nameJXSL2400095 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. LTD
2024/05/17Import · Class 2.2 Dostarlimab注射液 · No verified English nameJXSL2400094 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/05/17Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400093 Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD
2024/05/17Generic · Class 3 Amisulpride InjectionCYHS2401488 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2024/05/17Generic · Class 3 Amisulpride InjectionCYHS2401487 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2024/05/17Generic · Class 3 Bumetanide InjectionCYHS2401480 Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2024/05/17Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2401479 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/05/17Generic · Class 3 Metaraminol Tartrate InjectionCYHS2401477 Guangzhou Hui Feng De Bio Technology Co., Ltd. romanized; Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized
2024/05/17Generic · Class 3 Glyburide and Metformin Hydrochloride TabletsCYHS2401476 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2024/05/17Generic · Class 3 Glyburide and Metformin Hydrochloride TabletsCYHS2401475 Tong Hua Wan Tong Pharma Co., Ltd. romanized
2024/05/17Generic · Class 3 Diprophylline InjectionCYHS2401474 E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2024/05/17Generic · Class 3 Peramivir InjectionCYHS2401473 Zhejiang Kang Ji Er Pharma Co., Ltd. romanized
2024/05/17Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2401472 Jewim Pharmaceutical (Shandong) Co., Ltd.
2024/05/17New drug · Class 3.1 二冬颗粒 · No verified English nameCXZS2400016 Guizhou Wei Men Pharma Co., Ltd. romanized
2024/05/17New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2400329 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2024/05/17New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2400328 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2024/05/17New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2400327 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2024/05/17New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2400326 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2024/05/17New drug · Class 1 注射用重组WNV-HCD86 · No verified English nameCXSL2400325 Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized
2024/05/17New drug · Class 1 IBI3004 · No verified English nameCXSL2400324 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/05/17New drug · Class 1 ZL-82片 · No verified English nameCXHL2400510 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/17New drug · Class 1 ZL-82片 · No verified English nameCXHL2400509 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/17New drug · Class 1 ZL-82片 · No verified English nameCXHL2400508 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2024/05/17New drug · Class 1 KY-001 · No verified English nameCXHL2400507 Shanghai Qi Zhen Pharmaceuticals Technology Co., Ltd. romanized
2024/05/17New drug · Class 1 KY-001 · No verified English nameCXHL2400506 Shanghai Qi Zhen Pharmaceuticals Technology Co., Ltd. romanized
2024/05/17New drug · Class 2.4 恩那度司他片 · No verified English nameCXHL2400505 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/05/17New drug · Class 2.4 恩那度司他片 · No verified English nameCXHL2400504 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/05/17New drug · Class 2.4 恩那度司他片 · No verified English nameCXHL2400503 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/05/17New drug · Class 2.4 恩那度司他片 · No verified English nameCXHL2400502 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

109 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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