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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 372 drug applications between 6 September 2024 and 12 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 124, covering 85 drug names.

2024/09/06 – 2024/09/12

Period
2024/09/06 to 2024/09/12, 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
372
Drugs with new generic filings (by drug name, de-duplicated)
85
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

372filings, 124 of them generic

By application type

Application typeFilings
Supplement170
Generic124
New drug67
Import4
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug269
TCM63
Therapeutic biologic36
Prophylactic biologic2
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

85 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levocetirizine dihydrochloride Oral Solution525
2Nicardipine Hydrochloride Injection4213
3Acetylcysteine Solution For Inhalation334
4Lactulose Oral Solution3234
5Trazodone Hydrochloride Tablets325
6Sodium Bicarbonate Injection3210
7Brexpiprazole Orally Disintegrating Tablets3110
8Erythromycin Lactobionate for Injection3113
9注射用头孢唑肟钠 · No verified English name314
10Bilastine Tablets227

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

235 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized15140
2Gan Li Pharma Shandong Co., Ltd. romanized810
3Celgene Corporation610
4Suzhou Pai Rui Bio Technology Co., Ltd. romanized610
5Anhui Pioneer Pharmaceutical Co., Ltd534
6Hua Run Shuang He Pharma Co., Ltd. romanized510
7Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized431
8Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized420
9Shanghai Min Wei Bio Technology Co., Ltd. romanized420
10Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized423

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

122 this week

AcceptedDrugApplicants
2024/09/12Import · Class 1 AZD2936 · No verified English nameJXSL2400165 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/12Import · Class 2.2 利司扑兰片 · No verified English nameJXHS2400063 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd.
2024/09/12Generic · Class 3 Bilastine Oral SolutionCYHS2403050 Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/09/12Generic · Class 3 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2403047 Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2024/09/12Generic · Class 3 Levofloxacin Oral SolutionCYHS2403042 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/09/12Generic · Class 3 Sodium Thiosulfate InjectionCYHS2403037 Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2024/09/12Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2403035 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/09/12Generic · Class 3 盐酸西替利嗪滴眼液 · No verified English nameCYHL2400186 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2024/09/12New drug · Class 1 植物源重组人血清白蛋白注射液 · No verified English nameCXSS2400098 Wuhan He Yuan Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 2 抗A抗B血型定型试剂(单克隆抗体) · No verified English nameCXSS2400097 Changchun Bo Xun Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 2.4 注射用重组人透明质酸酶 · No verified English nameCXSS2400096 Shanghai Bao Ji Pharma Co., Ltd. romanized
2024/09/12New drug · Class 2.4 注射用重组人透明质酸酶 · No verified English nameCXSS2400095 Shanghai Bao Ji Pharma Co., Ltd. romanized
2024/09/12New drug · Class 1 EXG110注射液 · No verified English nameCXSL2400611 Hangzhou Jia Yin Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2400610 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/09/12New drug · Class 1 注射用ZL-1310 · No verified English nameCXSL2400609 Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/09/12New drug · Class 1 MWN105注射液 · No verified English nameCXSL2400608 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 MWN105注射液 · No verified English nameCXSL2400607 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 KH003注射液 · No verified English nameCXSL2400606 Sai Ling Pharma Technology Group Co., Ltd. romanized; Beijing Sai Ling Zhi Guang Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 MWN109注射液 · No verified English nameCXHL2400955 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 MWN109注射液 · No verified English nameCXHL2400954 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2400953 Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 MAX-40279-01胶囊 · No verified English nameCXHL2400952 Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 SS-001 软膏 · No verified English nameCXHL2400951 Suzhou Pai Rui Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 SS-001 软膏 · No verified English nameCXHL2400950 Suzhou Pai Rui Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 SS-001 软膏 · No verified English nameCXHL2400949 Suzhou Pai Rui Bio Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 CS060380片 · No verified English nameCXHL2400948 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 CS060380片 · No verified English nameCXHL2400947 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 CS060380片 · No verified English nameCXHL2400946 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 PR00012胶囊 · No verified English nameCXHL2400945 Beijing Zhe Yuan Technology Co., Ltd. romanized
2024/09/12New drug · Class 1 PR00012胶囊 · No verified English nameCXHL2400944 Beijing Zhe Yuan Technology Co., Ltd. romanized

92 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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