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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 225 drug applications between 5 April 2024 and 11 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 59 drug names.

2024/04/05 – 2024/04/11

Period
2024/04/05 to 2024/04/11, 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
225
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
0

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

225filings, 76 of them generic

By application type

Application typeFilings
Supplement84
Generic76
New drug37
Import18
Import re-registration7
Unspecified3

By drug type

Drug typeFilings
Chemical drug153
TCM37
Therapeutic biologic33
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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lidocaine and Prilocaine Cream2224
2Potassium Phosphates Injection222
3Levofloxacin Tablets227
4Isavuconazonium Sulfate for Injection2215
5盐酸肾上腺素注射液 · No verified English name226
6Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228
7Mirabegron Extended-release Tablets221
8腺苷钴胺胶囊 · No verified English name228
9Palbociclib Capsules210
10Multiple Electrolytes Injection(Ⅱ)211

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

156 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Boehringer Ingelheim International GmbH520
2Chen Huan Pharmaceuticals Group Co., Ltd. romanized440
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized430
4Guangxi Yu Yuan Pharma Co., Ltd. romanized420
5Shandong Feng Huang Pharmaceutical Co., Ltd. romanized330
6Qilu Pharmaceutical Co., Ltd.332
7Hainan Ai Ke Pharmaceutical Co., Ltd. romanized323
8Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized323
9A.Menarini Industrie Farmaceutiche Riunite S.r.l.310
10Celgene International II Sarl310

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

76 this week

AcceptedDrugApplicants
2024/04/11Import · Class 3.1 Ravulizumab注射液 · No verified English nameJXSL2400075 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/04/11Import · Class 1 BI 1819479 片 · No verified English nameJXHL2400089 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/04/11Import · Class 1 BI 1819479 片 · No verified English nameJXHL2400088 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/04/11Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2401085 Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/04/11Generic · Class 3 Haloperidol Lactate InjectionCYHS2401083 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2024/04/11Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2401078 Beijing Bei Lu Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/04/11New drug · Class 1 注射用金纳单抗 · No verified English nameCXSS2400040 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/04/11New drug · Class 1 注射用金纳单抗 · No verified English nameCXSS2400039 Changchun Jin Sai Pharma Co., Ltd. romanized
2024/04/11New drug · Class 1 注射用LM-2417 · No verified English nameCXSL2400223 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/04/11New drug · Class 1 YH001胶囊 · No verified English nameCXHL2400355 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2024/04/11New drug · Class 1 YH001胶囊 · No verified English nameCXHL2400354 Hangzhou Yu Hong Pharmaceuticals Technology Co., Ltd. romanized
2024/04/10Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400074 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2024/04/10Import · Class 1 Amycretin片 · No verified English nameJXSL2400073 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/04/10Import · Class 1 Amycretin片 · No verified English nameJXSL2400072 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/04/10Import · Class 1 Amycretin片 · No verified English nameJXSL2400071 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2024/04/10Import · Class 1 VAY736注射液 · No verified English nameJXSL2400070 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/04/10Generic · Class 3 注射用水溶性维生素 · No verified English nameCYHS2401073 Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2024/04/10Generic · Class 3 Potassium Chloride GranulesCYHS2401070 Chengdu Tong De Pharma Co., Ltd. romanized
2024/04/10Generic · Class 3 Ferrous Succinate TabletsCYHS2401069 Beijing Si Li An Pharma Co., Ltd. romanized
2024/04/10Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2401066 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2024/04/10Generic · Class 3 Minoxidil LinimentCYHS2401064 Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2024/04/10Generic · Class 3 Minoxidil LinimentCYHS2401063 Hangzhou Duan Ben Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
2024/04/10Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2401061 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/04/10Generic · Class 3 聚乙二醇钠钾散 · No verified English nameCYHS2401059 Ya An Xun Kang Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.
2024/04/10Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2401057 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/04/10Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401055 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/04/10Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401054 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/04/10Generic · Class 3 Potassium Phosphates InjectionCYHS2401053 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/04/10Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2400070 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
2024/04/10New drug · Class 1 U87注射液 · No verified English nameCXSL2400222 Shanghai You Ka Di Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai You Ka Di Zhi Zao Sheng Ming Technology Co., Ltd. romanized

46 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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