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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 1 August 2024 and 7 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 69 drug names.

2024/08/01 – 2024/08/07

Period
2024/08/01 to 2024/08/07, 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
342
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
1

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

342filings, 85 of them generic

By application type

Application typeFilings
Supplement178
Generic85
New drug41
Import28
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug232
TCM60
Therapeutic biologic43
Prophylactic biologic5
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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Azilsartan Medoxomil Potassium Tablets4235
2Morinidazole and Sodium Chloride Injection229
3Pediatric Faropenem Sodium Granules222
4Isavuconazonium Sulfate for Injection2215
5维生素B6注射液 · No verified English name2210
6Piracetam Injection219
7Vonoprazan Fumarate Tablets2160
8昂丹司琼口溶膜 · No verified English name212
9Tranexamic Acid Tablets219
10Potassium Chloride Oral Solution2111

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

223 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Boehringer Ingelheim International GmbH1520
2Hunan San Xue Pharma Co., Ltd. romanized760
3Shandong Qidu Pharmaceutical Co., Ltd.554
4Chengdu Brilliant Pharmaceutical Co., Ltd.544
5Guangdong Ke Hong Pharma Co., Ltd. romanized510
6Jenapharm GmbH & Co. KG440
7Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
8Janssen Research & Development LLC420
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

106 this week

AcceptedDrugApplicants
2024/08/07Import · Class 1 注射用M9140 · No verified English nameJXSL2400146 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd.
2024/08/07Import · Class 2.4 盐酸伊普可泮胶囊 · No verified English nameJXHS2400053 Novartis Pharma Schweiz AG; Novartis Pharma Produktions GmbH; Beijing Novartis Pharma Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400197 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400196 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400195 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400194 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400193 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400192 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400191 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400190 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400189 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400188 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400187 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400186 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400185 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Import · Class 1 BI 456906 注射液 · No verified English nameJXHL2400184 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/08/07Generic · Class 3 Citicoline Sodium InjectionCYHS2402514 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/08/07Generic · Class 3 Piracetam InjectionCYHS2402512 Xizang Hai Jin Pharma Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/08/07Generic · Class 3 Piracetam InjectionCYHS2402511 Xizang Hai Jin Pharma Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/08/07Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G4.25%) · No verified English nameCYHS2402510 Shandong Qidu Pharmaceutical Co., Ltd.
2024/08/07Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2402509 Shandong Qidu Pharmaceutical Co., Ltd.
2024/08/07Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2402508 Shandong Qidu Pharmaceutical Co., Ltd.
2024/08/07Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2402506 Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized
2024/08/07Generic · Class 3 Levofolinate Calcium for InjectionCYHS2402504 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/08/07New drug · Class 2.2 注射用重组人尿激酶原 · No verified English nameCXSS2400083 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2024/08/07New drug · Class 1 GQ1010注射液 · No verified English nameCXSL2400523 Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2024/08/07New drug · Class 1 NH600001乳状注射液 · No verified English nameCXHL2400780 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/08/07New drug · Class 1 PBSS1113肠溶片 · No verified English nameCXHL2400779 Hangzhou Pu Ji Yuan Cheng Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/07New drug · Class 1 PBSS1113肠溶片 · No verified English nameCXHL2400778 Hangzhou Pu Ji Yuan Cheng Biopharmaceuticals Technology Co., Ltd. romanized
2024/08/07New drug · Class 2.4 注射用紫杉醇聚合物胶束 · No verified English nameCXHL2400777 Shanghai Yi Zhong Pharma Co., Ltd. romanized

76 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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