YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 358 drug applications between 4 November 2024 and 10 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 101, covering 76 drug names.

2024/11/04 – 2024/11/10

Period
2024/11/04 to 2024/11/10, 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
358
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
4

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

358filings, 101 of them generic

By application type

Application typeFilings
Supplement159
Generic101
New drug63
Import17
Import re-registration15
Unspecified3

By drug type

Drug typeFilings
Chemical drug285
TCM39
Therapeutic biologic29
Prophylactic biologic3
In vitro diagnostic reagent1
Biologic1

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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution4223
3Methotrexate Injection3211
4Repaglinide Tablets316
5Dydrogesterone Tablets228
6Iguratimod Tablets2223
7Piracetam Injection219
8布比卡因脂质体注射液 · No verified English name217
9Potassium Chloride Granules214
10盐酸西替利嗪滴剂 · No verified English name218

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangdong Sunho Pharmaceutical Co., Ltd.17100
2Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized980
3Qilu Pharmaceutical Co., Ltd.742
4Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized660
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
6GE Healthcare AS610
7Teva Neuroscience Inc.610
8Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized610
9SANOFI WINTHROP INDUSTRIE530
10Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520

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

112 this week

AcceptedDrugApplicants
2024/11/09Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2403839 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/09Generic · Class 3 Potassium Chloride GranulesCYHS2403838 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2024/11/09Generic · Class 3 Potassium Chloride GranulesCYHS2403837 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2024/11/09Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403836 Changchun Hai Yue Pharma Co., Ltd. romanized
2024/11/09Generic · Class 3 Eptazocine Hydrobromide InjectionCYHS2403831 Chengdu Brilliant Pharmaceutical Co., Ltd.
2024/11/09Generic · Class 3 Nicergoline TabletsCYHS2403829 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2024/11/09New drug · Class 1 注射用AMT-754 · No verified English nameCXSL2400760 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/11/09New drug · Class 1 J-51注射液 · No verified English nameCXSL2400759 Jin Wei Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/09New drug · Class 1 SAR444656 · No verified English nameCXHL2401212 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2024/11/09New drug · Class 1 SAR444656 · No verified English nameCXHL2401211 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2024/11/09New drug · Class 1 NSP-1047A片 · No verified English nameCXHL2401210 Nuo Wo Si Da Pharma (Shanghai) Co., Ltd. romanized
2024/11/09New drug · Class 1 NSP-1047A片 · No verified English nameCXHL2401209 Nuo Wo Si Da Pharma (Shanghai) Co., Ltd. romanized
2024/11/09New drug · Class 1 GH56胶囊 · No verified English nameCXHL2401208 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/11/09New drug · Class 1 GH56胶囊 · No verified English nameCXHL2401207 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/11/09New drug · Class 1 GH56胶囊 · No verified English nameCXHL2401206 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/11/09New drug · Class 1 ASN-3186胶囊 · No verified English nameCXHL2401205 Shanghai Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2024/11/08Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2403823 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized
2024/11/08New drug · Class 1.1 苓仙颗粒 · No verified English nameCXZL2400077 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2024/11/08New drug · Class 1 IBI3010 · No verified English nameCXSL2400758 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/11/08New drug · Class 1 注射用SIBP-A19 · No verified English nameCXSL2400757 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2024/11/08New drug · Class 1 RGL-2201注射液 · No verified English nameCXSL2400756 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized
2024/11/08New drug · Class 1 注射用YK012 · No verified English nameCXSL2400755 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2024/11/08New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2400754 Qilu Pharmaceutical Co., Ltd.
2024/11/08New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2400753 Qilu Pharmaceutical Co., Ltd.
2024/11/08New drug · Class 1.2 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400752 Da Mian Yi Miao (Guangzhou) Co., Ltd. romanized; Hua Lan Bio Yi Miao Co., Ltd. romanized
2024/11/08New drug · Class 1 ASN-3186胶囊 · No verified English nameCXHL2401204 Shanghai Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 2.2 HXHTT024 · No verified English nameCXHL2401203 Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2401202 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2401201 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/08New drug · Class 1 HS-10518胶囊 · No verified English nameCXHL2401200 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized

82 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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