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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 431 drug applications between 7 September 2024 and 13 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 132, covering 92 drug names.

2024/09/07 – 2024/09/13

Period
2024/09/07 to 2024/09/13, 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
431
Drugs with new generic filings (by drug name, de-duplicated)
92
Accepted this week, now under review
6

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

431filings, 132 of them generic

By application type

Application typeFilings
Supplement206
Generic132
New drug81
Import5
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug308
TCM67
Therapeutic biologic51
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

92 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levocetirizine dihydrochloride Oral Solution525
2Nicardipine Hydrochloride Injection4213
3Lactulose Oral Solution3234
4Trazodone Hydrochloride Tablets325
5Sodium Bicarbonate Injection3210
6Brexpiprazole Orally Disintegrating Tablets3110
7Brexpiprazole Tablets3131
8Erythromycin Lactobionate for Injection3113
9注射用头孢唑肟钠 · No verified English name314
10Acetylcysteine Solution For Inhalation224

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

257 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized30290
2Gan Li Pharma Shandong Co., Ltd. romanized810
3Celgene Corporation610
4Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
5Suzhou Pai Rui Bio Technology Co., Ltd. romanized610
6Shanxi Hua Kang Pharma Co., Ltd. romanized540
7Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized520
8Hua Run Shuang He Pharma Co., Ltd. romanized510
9Xian Zi Li Pharmaceutical Technology Co., Ltd. romanized440
10Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized431

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

145 this week

AcceptedDrugApplicants
2024/09/13Import · Class 3.1 20价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2400166 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2024/09/13Generic · Class 3 Fat-Soluble Vitamin Injection(Ⅰ)CYHS2403071 Shenyang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/09/13Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2403070 Nanjing Hai Jing Pharma Co., Ltd. romanized
2024/09/13Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2403069 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/09/13Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2403068 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/09/13Generic · Class 3 Famotidine InjectionCYHS2403065 Zhuhai Heng Qin Guo Yan Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/09/13Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2403064 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2024/09/13Generic · Class 3 Minoxidil LinimentCYHS2403058 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2024/09/13Generic · Class 3 Minoxidil LinimentCYHS2403057 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2024/09/13Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2403056 Jiangsu He Chen Pharma Co., Ltd. romanized
2024/09/13Generic · Class 3 Pregabalin Orally Disintegrating TabletsCYHS2403055 Jiangsu He Chen Pharma Co., Ltd. romanized
2024/09/13New drug · Class 1 TAEST16001注射液 · No verified English nameCXSL2400618 Xiang Xue Sheng Ming Ke Xue Technology (Guangdong) Co., Ltd. romanized
2024/09/13New drug · Class 1 EMB-09注射液 · No verified English nameCXSL2400617 Shanghai An Mai Bio Technology Co., Ltd. romanized
2024/09/13New drug · Class 2.2 恩朗苏拜单抗注射液 · No verified English nameCXSL2400616 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/09/13New drug · Class 1 外用RGL-2102 · No verified English nameCXSL2400615 Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized
2024/09/13New drug · Class 1 RG002注射液 · No verified English nameCXSL2400614 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized
2024/09/13New drug · Class 1 注射用BL-M08D1 · No verified English nameCXSL2400613 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/09/13New drug · Class 1 注射用SKB501 · No verified English nameCXSL2400612 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2024/09/13New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHL2400966 Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized
2024/09/13New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHL2400965 Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized
2024/09/13New drug · Class 1 SZ2726片 · No verified English nameCXHL2400964 Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized
2024/09/13New drug · Class 1 SZ2726片 · No verified English nameCXHL2400963 Su Zhong Pharma Group Co., Ltd. romanized; Jiangsu Su Zhong Pharma Research Institute Co., Ltd. romanized
2024/09/13New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2400962 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/09/13New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2400961 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/09/13New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2400960 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/09/13New drug · Class 2.3 SMF-203 · No verified English nameCXHL2400959 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/09/13New drug · Class 1 普那布林注射用浓溶液 · No verified English nameCXHL2400958 Da Lian Wan Chun Bu Lin Pharmaceuticals Co., Ltd. romanized
2024/09/13New drug · Class 1 JMKX004649片 · No verified English nameCXHL2400957 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2024/09/13New drug · Class 1 JMKX004649片 · No verified English nameCXHL2400956 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2024/09/12Import · Class 1 AZD2936 · No verified English nameJXSL2400165 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.

115 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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