YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 363 drug applications between 28 July 2024 and 3 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 78 drug names.

2024/07/28 – 2024/08/03

Period
2024/07/28 to 2024/08/03, 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
363
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
12

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

363filings, 103 of them generic

By application type

Application typeFilings
Supplement182
Generic103
New drug52
Import14
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug233
TCM64
Therapeutic biologic57
Prophylactic biologic7
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

78 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Azilsartan Medoxomil Potassium Tablets4235
2Potassium Chloride Oral Solution3211
3Bromhexine Hydrochloride Oral Solution3222
4Neostigmine Methylsulfate Injection314
5Magnesium Sulfate Injection317
6Diquafosol Sodium Eye Drops225
7Pediatric Faropenem Sodium Granules222
8Isavuconazonium Sulfate for Injection2215
9维生素B6注射液 · No verified English name2210
10Procaterol Hydrochloride Solution for Inhalation212

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

238 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hunan San Xue Pharma Co., Ltd. romanized14110
2Ha Yao Group Pharmaceutical Factory romanized1120
3Shen Wei Pharma Group Co., Ltd. romanized550
4Guangdong Ke Hong Pharma Co., Ltd. romanized510
5Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized510
6Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
7Janssen Research & Development LLC420
8Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized423
9Eli Lilly and Company410
10Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized410

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

107 this week

AcceptedDrugApplicants
2024/08/03Import · Class 2.2 佩索利单抗注射液 · No verified English nameJXSL2400145 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/03Import · Class 1 HDP-101 · No verified English nameJXSL2400144 Heidelberg Pharma AG; Hangzhou Zhongmei HuaDong Pharmaceutical Co. Ltd.
2024/08/03Import · Class 1 ASP2138注射液 · No verified English nameJXSL2400143 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2024/08/03Import · Class 1 JNJ-78278343注射液 · No verified English nameJXSL2400142 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/03Import · Class 1 JNJ-78278343注射液 · No verified English nameJXSL2400141 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/08/03Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2402479 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2024/08/03Generic · Class 3 昂丹司琼口溶膜 · No verified English nameCYHS2402478 Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized
2024/08/03Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2402477 Anhui Ji Ren Pharma Co., Ltd. romanized
2024/08/03Generic · Class 3 Potassium Chloride Oral SolutionCYHS2402475 Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2024/08/03Generic · Class 3 Potassium Chloride Oral SolutionCYHS2402474 Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2024/08/03Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2402472 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2024/08/03Generic · Class 3 Etoposide InjectionCYHS2402468 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/08/03Generic · Class 3 阿巴帕肽注射液 · No verified English nameCYHL2400159 Qilu Pharmaceutical Co., Ltd.
2024/08/03New drug · Class 1 GQ1005注射液 · No verified English nameCXSL2400522 Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2024/08/03New drug · Class 1 注射用PTX-912 · No verified English nameCXSL2400521 Bo Zhi Bio Technology (Shanghai) Co., Ltd. romanized
2024/08/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400520 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/08/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400519 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/08/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400518 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/08/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400517 Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Nuo Bo Te Bio Technology Co., Ltd. romanized
2024/08/03New drug · Class 1 YFQLXB-UC01注射液 · No verified English nameCXSL2400516 Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized
2024/08/03New drug · Class 1 ZM001注射液 · No verified English nameCXSL2400515 Xiamen Zai Miao Bio Technology Co., Ltd. romanized
2024/08/02Import · Class 3.1 elranatamab · No verified English nameJXSL2400140 Pfizer Inc.; Pfizer Investment Co. Ltd.
2024/08/02Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400139 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/08/02Import · Class 3.1 注射用sotatercept · No verified English nameJXSL2400138 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/08/02Generic · Class 3 Foscarnet Sodium InjectionCYHS2402461 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2024/08/02Generic · Class 3 Amisulpride Oral SolutionCYHS2402458 Wan Te Pharmaceutical (Hainan) Co., Ltd. romanized
2024/08/02Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2402451 Beijing SL Pharmaceutical Co., Ltd.
2024/08/02Generic · Class 3 布美他尼片 · No verified English nameCYHS2402450 Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2024/08/02New drug · Class 1.2 冻干带状疱疹mRNA疫苗 · No verified English nameCXSL2400514 Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized
2024/08/02New drug · Class 1 IHS002赋能人脐带间充质干细胞注射液 · No verified English nameCXSL2400513 Wuxi Hua Tai Innovation Yao Technology Research Institute Co., Ltd. romanized

77 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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