YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 372 drug applications between 22 March 2025 and 28 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 61 drug names.

2025/03/22 – 2025/03/28

Period
2025/03/22 to 2025/03/28, 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
372
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
23

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

372filings, 86 of them generic

By application type

Application typeFilings
Supplement184
Generic86
New drug50
Import41
Import re-registration8
Unspecified3

By drug type

Drug typeFilings
Chemical drug252
Therapeutic biologic61
TCM53
Prophylactic biologic6

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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Glucosamine Sulfate Capsules4451
2Upadacitinib Sustained-release Tablets4243
3Sodium Nitroprusside Injection3315
4Diclofenac Diethylamine Emulgel3220
5Paliperidone Palmitate Injection318
6Sacubitril Valsartan Sodium Tablets3170
7Ferrous Succinate Tablets2220
8Apalutamide Tablets2218
9Calcitriol Injection220
10Vonoprazan Fumarate Tablets2160

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

217 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized990
2Amgen Inc.930
3Roche Pharma(Schweiz)AG810
4Eli Lilly and Company720
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
6Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized660
7Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.620
8Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized550
9Sanofi Winthrop Industrie520
10Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized444

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

119 this week

AcceptedDrugApplicants
2025/03/28Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500038 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 3.1 度伐利尤单抗注射液 · No verified English nameJXSS2500037 AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/03/28Import · Class 1 Empasiprubart注射用浓溶液 · No verified English nameJXSL2500047 argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd.
2025/03/28Import · Class 1 PF-07985045片 · No verified English nameJXHL2500066 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 PF-07985045片 · No verified English nameJXHL2500065 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500064 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500063 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500062 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500061 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500060 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Import · Class 1 Orforglipron胶囊 · No verified English nameJXHL2500059 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/28Generic · Class 3 Epinastine Hydrochloride Eye DropsCYHS2501218 Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized
2025/03/28Generic · Class 3 Famotidine InjectionCYHS2501216 Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized
2025/03/28Generic · Class 3 Famotidine InjectionCYHS2501215 Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Gansu Cheng Ji Bio Pharma Co., Ltd. romanized
2025/03/28Generic · Class 3 Dyclonine Topical SolutionCYHL2500073 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/28Generic · Class 3 溴莫尼定凝胶 · No verified English nameCYHL2500072 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/03/28New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500026 Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanized
2025/03/28New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2500025 Nan Tong Hui Ju Pharmaceutical Co., Ltd. romanized
2025/03/28New drug · Class 1 DZD6008片 · No verified English nameCXHL2500342 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/28New drug · Class 1 DZD6008片 · No verified English nameCXHL2500341 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/28New drug · Class 1 DZD6008片 · No verified English nameCXHL2500340 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Di Zhe (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/03/28New drug · Class 1 AOD113408注射液 · No verified English nameCXHL2500339 Chengdu Ao Da Bio Technology Co., Ltd. romanized
2025/03/28New drug · Class 2.2 WS-011 · No verified English nameCXHL2500337 Hubei Wu Shi Pharma Co., Ltd. romanized
2025/03/28New drug · Class 1 EDP167注射液 · No verified English nameCXHL2500336 Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized
2025/03/28New drug · Class 1 VVN432鼻喷雾剂 · No verified English nameCXHL2500335 Wei Mou Bio Technology (Zhejiang) Co., Ltd. romanized
2025/03/28New drug · Class 1 VVN432鼻喷雾剂 · No verified English nameCXHL2500334 Wei Mou Bio Technology (Zhejiang) Co., Ltd. romanized
2025/03/28New drug · Class 2.3 EP-0203XR · No verified English nameCXHL2500333 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2025/03/27Import · Class 2.1 仑卡奈单抗注射液(皮下注射) · No verified English nameJXSL2500046 Eisai Co. Ltd.; Eisai China Inc.
2025/03/27Import · Class 1 TPST-1120片 · No verified English nameJXHL2500058 Tempest Therapeutics Inc.; Novotech Clinical Services (Shanghai) Co. Ltd.
2025/03/27Import · Class 2.4 Megestrol Acetate Oral SuspensionJXHL2500056 TWi Pharmaceuticals Inc.; Changchun GeneScience Pharmaceuticals Co. Ltd.

89 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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