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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 343 drug applications between 29 January 2024 and 4 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 77 drug names.

2024/01/29 – 2024/02/04

Period
2024/01/29 to 2024/02/04, 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
343
Drugs with new generic filings (by drug name, de-duplicated)
77
Accepted this week, now under review
8

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

343filings, 106 of them generic

By application type

Application typeFilings
Supplement154
Generic106
New drug48
Import17
Unspecified9
Import re-registration9

By drug type

Drug typeFilings
Chemical drug230
Therapeutic biologic53
TCM48
Prophylactic biologic8
Biologic4

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

77 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment5152
2Vonoprazan Fumarate Tablets4260
3Lidocaine and Prilocaine Cream3324
4LevomilnacipranHydrochloride Extended-release Capsules316
5Peramivir Injection227
6Dronedarone Hydrochloride Tablets224
7Metoclopramide Hydrochloride Injection226
8Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228
9Nintedanib Esilate Soft Capsules216
10Diquafosol Sodium Eye Drops215

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

228 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

102 this week

AcceptedDrugApplicants
2024/02/03Import · Class 3.1 重组带状疱疹疫苗(CHO细胞) · No verified English nameJXSS2400007 GlaxoSmithKline Biologicals SA
2024/02/03Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2400033 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/02/03Import · Class 2.2 Ravulizumab注射液 · No verified English nameJXSL2400032 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2024/02/03Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHS2400473 Sichuan Bai Li Pharma Co., Ltd. romanized
2024/02/03Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHS2400472 Sichuan Bai Li Pharma Co., Ltd. romanized
2024/02/03Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2400469 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2024/02/03Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400468 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/02/03Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400466 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2024/02/03Generic · Class 3 Halcinonide Topical SolutionCYHS2400457 Xuan Cheng Shi Zhong Cheng Pharmaceuticals Co., Ltd. romanized; Fu Yuan Pharma Co., Ltd. romanized
2024/02/03Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2400455 Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2024/02/03Generic · Class 3 Finasteride and Tadalafil CapsulesCYHS2400454 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
2024/02/03Generic · Class 3 Bumetanide InjectionCYHS2400453 Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2024/02/03Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2400449 Sen Miao (Shandong) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2024/02/03Generic · Class 3 Arformoterol Tartrate Inhalation SolutionCYHL2400034 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/02/03Generic · Class 3 右美沙芬安非他酮缓释片 · No verified English nameCYHL2400033 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/02/03New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2400092 Shenzhen Shi Bei Ke Bio Technology Co., Ltd. romanized
2024/02/03New drug · Class 2.2 索卡佐利单抗注射液 · No verified English nameCXSL2400091 Zhao Ke (Guangzhou) Zhong Liu Drug Co., Ltd. romanized
2024/02/03New drug · Class 1 KH658眼用注射液 · No verified English nameCXSL2400090 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2024/02/03New drug · Class 1 KH658眼用注射液 · No verified English nameCXSL2400089 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2024/02/03New drug · Class 1 KH658眼用注射液 · No verified English nameCXSL2400088 Chengdu Hong Ji Bio Technology Co., Ltd. romanized
2024/02/03New drug · Class 1 SSGJ-707注射液 · No verified English nameCXSL2400087 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2024/02/02Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2400031 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/02/02Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2400030 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2024/02/02Generic · Class 3 Methocarbamol InjectionCYHS2400448 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/02/02Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2400436 Hebei Long Hai Pharma Co., Ltd. romanized
2024/02/02Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHL2400031 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/02/02Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHL2400030 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/02/02Generic · Class 3 LevomilnacipranHydrochloride Extended-release CapsulesCYHL2400029 Jiangsu En Hua Pharma Co., Ltd. romanized
2024/02/02New drug · Class 1.1 七味脂肝颗粒 · No verified English nameCXZL2400008 Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized
2024/02/02New drug · Class 1.1 青杏颗粒 · No verified English nameCXZL2400007 Guangzhou Zhong Pharmaceuticals University (Guangzhou Zhong Pharmaceuticals Research Institute) romanized

72 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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