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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 218 drug applications between 15 February 2024 and 21 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 64, covering 52 drug names.

2024/02/15 – 2024/02/21

Period
2024/02/15 to 2024/02/21, 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
218
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
7

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

218filings, 64 of them generic

By application type

Application typeFilings
Supplement107
Generic64
New drug35
Import9
Import re-registration2
Unspecified1

By drug type

Drug typeFilings
Chemical drug149
TCM39
Therapeutic biologic28
Prophylactic 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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
2Topiroxostat Tablets310
3Latamoxef Sodium for Injection311
4Acetylcysteine Granules214
5Toremifene Citrate Tablets210
6Piperacillin Sodium for Injection2116
7Azilsartan Medoxomil Potassium Tablets2135
8Esomeprazole Magnesium for Delayed-release Oral Suspension214
9Fluvoxamine Maleate Tablets210
10Sodium Valproate Oral Solution111

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

142 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized10100
2CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.1030
3Sichuan Yi Ke Cao Pharma Co., Ltd. romanized660
4Qi Lu An Ti Pharmaceutical Co., Ltd. romanized623
5Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized410
6Haerbin Kang Ze Yuan Pharma Co., Ltd. romanized330
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.332
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized330
9Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized323
10Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized323

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

79 this week

AcceptedDrugApplicants
2024/02/21Import · Class 1 MEDI5752 · No verified English nameJXSL2400048 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/02/21Import · Class 1 AMG 451 · No verified English nameJXSL2400047 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/02/21Generic · Class 3 Acetylcysteine InjectionCYHS2400664 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/02/21Generic · Class 3 立他司特滴眼液 · No verified English nameCYHS2400663 Qilu Pharmaceutical Co., Ltd.
2024/02/21Generic · Class 3 Olopatadine Hydrochloride GranulesCYHS2400662 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/02/21Generic · Class 3 Deoxycholic Acid InjectionCYHS2400661 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/02/21Generic · Class 3 利奈唑胺氯化钠注射液 · No verified English nameCYHS2400655 Da Xiang Pharmaceuticals Group Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2024/02/21Generic · Class 3 Minoxidil LinimentCYHS2400654 Yao Da Pharmaceutical Co., Ltd. romanized
2024/02/21Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2400653 Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2024/02/21Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2400652 Hubei Xin Ze Fei Pharma Co., Ltd. romanized
2024/02/21Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2400651 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/02/21Generic · Class 3 Cimetidine InjectionCYHS2400649 Shanxi Hui Da Lin Xi Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized
2024/02/21Generic · Class 3 Metaraminol Tartrate InjectionCYHS2400647 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/02/21Generic · Class 3 Furosemide TabletsCYHS2400646 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/02/21New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2400138 Chengdu Xin Nuo Ming Bio Technology Co., Ltd. romanized; Chengdu Ou Lin Bio Technology Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized
2024/02/21New drug · Class 1 司普奇拜单抗注射液 · No verified English nameCXSL2400137 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2024/02/21New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2400136 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/02/21New drug · Class 3.3 达雷妥尤单抗注射液 · No verified English nameCXSL2400135 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/02/21New drug · Class 2.1 JS001sc注射液 · No verified English nameCXSL2400134 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/02/21New drug · Class 1 SSS39注射剂 · No verified English nameCXHL2400204 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2024/02/21New drug · Class 1 SG1001片 · No verified English nameCXHL2400203 Shenzhen Shi Xiang Gen Bio Co., Ltd. romanized
2024/02/21New drug · Class 2.4; 2.3 JP001片 · No verified English nameCXHL2400202 Beijing Hui Bao Yuan Bio Technology Co., Ltd. romanized
2024/02/21New drug · Class 1 吸入用XQ-001 · No verified English nameCXHL2400201 Chengdu Bei Te Xin Qi Biopharmaceuticals Co., Ltd. romanized
2024/02/20Import · Class 2.4 布地奈德硫酸沙丁胺醇吸入气雾剂 · No verified English nameJXHL2400036 AstraZeneca Pharmaceuticals LP; AstraZeneca Global R&D (China) Co. Ltd.
2024/02/20Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2400642 Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized
2024/02/20Generic · Class 3 Isoniazid InjectionCYHS2400641 Hebei Long Hai Pharma Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/02/20Generic · Class 3 Latamoxef Sodium for InjectionCYHS2400637 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Latamoxef Sodium for InjectionCYHS2400636 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Latamoxef Sodium for InjectionCYHS2400635 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2400633 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized

49 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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