YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 335 drug applications between 9 April 2025 and 15 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 76 drug names.

2025/04/09 – 2025/04/15

Period
2025/04/09 to 2025/04/15, 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
335
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
37

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

335filings, 101 of them generic

By application type

Application typeFilings
Supplement159
Generic101
New drug49
Import18
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug234
TCM64
Therapeutic biologic31
Prophylactic biologic5
Biologic1

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets5270
2Dopamine Hydrochloride Injection423
3Finerenone Tablets3269
4Ampicillin Sodium For Injection315
5Upadacitinib Sustained-release Tablets2243
6Bisoprolol Fumarate and Amlodipine Besylate Tablets229
7Iguratimod Tablets2223
8Ilaprazole Enteric-coated Tablets2226
9Iron Proteinsuccinylate Oral Solution2226
10Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ)225

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

221 companies with new acceptances; top 10 listed

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

101 this week

AcceptedDrugApplicants
2025/04/15Import · Class 2.4 Seladelpar胶囊 · No verified English nameJXHL2500081 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2025/04/15Import · Class 2.4 Seladelpar胶囊 · No verified English nameJXHL2500080 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2025/04/15Import · Class 1 AZD6234注射液 · No verified English nameJXHL2500079 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/15Import · Class 1 AZD9550注射液 · No verified English nameJXHL2500078 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/15Import · Class 1 AZD9550注射液 · No verified English nameJXHL2500077 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/04/15Generic · Class 3 盐酸丙卡特罗吸入溶液 · No verified English nameCYHS2501431 Shijiazhuang Di Si Kai Wei Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Gree Pharmaceutical Co., Ltd
2025/04/15Generic · Class 3 Potassium Aspartate InjectionCYHS2501430 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/04/15Generic · Class 3 Simethicone Chewable TabletsCYHS2501429 Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized
2025/04/15New drug · Class 3.4 人纤维蛋白原 · No verified English nameCXSS2500045 Nan Yue Biopharmaceutical Co., Ltd. romanized
2025/04/15New drug · Class 1 SHR-2173注射液 · No verified English nameCXSL2500298 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/04/15New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500297 Yuan Pin Xi Bao Bio Technology Group Co., Ltd. romanized
2025/04/15New drug · Class 1 KY2液体硬胶囊 · No verified English nameCXHL2500387 Shenzhen Kai Yue Sheng Ming Technology Co., Ltd. romanized
2025/04/15New drug · Class 1 YJH-012注射液 · No verified English nameCXHL2500386 Li Zhu Pharmaceuticals Group Co., Ltd. romanized
2025/04/14Generic · Class 3 Ampicillin Sodium For InjectionCYHS2501427 Shandong An Xin Pharmaceutical Co., Ltd. romanized
2025/04/14Generic · Class 3 Ampicillin Sodium For InjectionCYHS2501426 Shandong An Xin Pharmaceutical Co., Ltd. romanized
2025/04/14Generic · Class 3 Ampicillin Sodium For InjectionCYHS2501425 Shandong An Xin Pharmaceutical Co., Ltd. romanized
2025/04/14Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2501424 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/04/14Generic · Class 3 Glycopyrronium Bromide and Neostigmine Metilsulfate InjectionCYHL2500080 Chengdu Nuo He Cheng Hong Biopharmaceutical Co., Ltd. romanized
2025/04/14New drug · Class 2.1 GD-19乳状注射液 · No verified English nameCXHL2500385 Tianjin Gu Dui Biopharmaceuticals Technology Co., Ltd. romanized
2025/04/12Generic · Class 3 Multiple Vitamins InjectionCYHS2501413 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/04/12Generic · Class 3 Sodium Thiosulfate InjectionCYHS2501410 Hubei Cheng Jian Pharma Co., Ltd. romanized; Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized
2025/04/12Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2501408 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/04/12New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2500296 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2025/04/12New drug · Class 1 注射用RGL-232 · No verified English nameCXSL2500295 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized
2025/04/12New drug · Class 2.2 LN2222 · No verified English nameCXHL2500384 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/04/12New drug · Class 2.2 LN2222 · No verified English nameCXHL2500383 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/04/11Import · Class 1.4 21价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2500058 Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd.
2025/04/11Generic · Class 3 Vitamin K1 InjectionCYHS2501407 Hainan Quan Ying Pharma Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2025/04/11Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2501406 Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized; Chongqing He Ping Pharmaceutical Co., Ltd. romanized
2025/04/11Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2501404 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized

71 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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