YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 342 drug applications between 2 August 2024 and 8 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 72 drug names.

2024/08/02 – 2024/08/08

Period
2024/08/02 to 2024/08/08, 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)
72
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, 90 of them generic

By application type

Application typeFilings
Supplement168
Generic90
New drug33
Import26
Unspecified20
Import re-registration5

By drug type

Drug typeFilings
Chemical drug227
TCM54
Therapeutic biologic45
Biologic11
Prophylactic biologic5

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

72 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Azilsartan Medoxomil Potassium Tablets4235
2Pioglitazone and Metformin Hydrochloride Tablets2210
3氯化钙注射液 · No verified English name226
4Isavuconazonium Sulfate for Injection2215
5Piracetam Injection219
6Vonoprazan Fumarate Tablets2160
7昂丹司琼口溶膜 · No verified English name212
8Potassium Chloride Oral Solution2111
9Famotidine Injection218
10Metoprolol Succinate Extended-release Capsules214

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

213 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Boehringer Ingelheim International GmbH1520
2Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized810
3Hunan San Xue Pharma Co., Ltd. romanized760
4Novo Nordisk A/S620
5Shandong Qidu Pharmaceutical Co., Ltd.554
6Guangdong Ke Hong Pharma Co., Ltd. romanized510
7Jenapharm GmbH & Co. KG440
8Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
9Shenyang Hong Yao Group Co., Ltd. romanized440
10Chengdu Brilliant Pharmaceutical Co., Ltd.433

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

98 this week

AcceptedDrugApplicants
2024/08/08Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2402530 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2024/08/08Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2402529 Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized
2024/08/08Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2402528 Hainan He Rui Da Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/08/08Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2402527 Beijing Foyou Pharma CO.,LTD
2024/08/08Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2402526 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2024/08/08Generic · Class 3 Digoxin InjectionCYHS2402524 Jiangxi He Ying Pharma Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2024/08/08Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2402521 Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/08/08Generic · Class 3 Ketotifen Fumarate Oral SolutionCYHS2402516 Wuhan Bei Can Pharma Co., Ltd. romanized
2024/08/08New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2400525 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2024/08/08New drug · Class 1 HD004细胞 · No verified English nameCXSL2400524 Hua Dao (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2024/08/08New drug · Class 1 注射用SPN01 · No verified English nameCXHL2400782 Beijing Sheng Guang Na Medical Technology Co., Ltd. romanized
2024/08/08New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2400781 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
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

68 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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