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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 359 drug applications between 8 April 2024 and 14 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 79 drug names.

2024/04/08 – 2024/04/14

Period
2024/04/08 to 2024/04/14, 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
359
Drugs with new generic filings (by drug name, de-duplicated)
79
Accepted this week, now under review
1

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

359filings, 104 of them generic

By application type

Application typeFilings
Supplement154
Generic104
New drug62
Import20
Import re-registration12
Unspecified7

By drug type

Drug typeFilings
Chemical drug253
TCM53
Therapeutic biologic42
Prophylactic biologic6
Biologic5

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

79 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution338
2Lidocaine and Prilocaine Cream2224
3Potassium Phosphates Injection222
4Levofloxacin Tablets227
5Pranoprofen Eye Drops227
6氟比洛芬凝胶贴膏 · No verified English name2216
7Ademetionine 1,4 - Butanedisulfonate For Injection222
8Isavuconazonium Sulfate for Injection2215
9盐酸肾上腺素注射液 · No verified English name226
10Mirabegron Extended-release Tablets221

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

#Company (first applicant)FilingsDrugsGeneric
1Jiangsu Hao Sen Pharma Group Co., Ltd. romanized810
2Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized550
3Boehringer Ingelheim International GmbH520
4Chen Huan Pharmaceuticals Group Co., Ltd. romanized440
5Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized430
6Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized430
7Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized422
8Guangxi Yu Yuan Pharma Co., Ltd. romanized420
9Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized420
10Seagen Inc.410

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

110 this week

AcceptedDrugApplicants
2024/04/13Generic · Class 3 Sodium Nitroprusside InjectionCYHS2401109 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2024/04/13Generic · Class 3 Cimetidine InjectionCYHS2401106 Shijiazhuang Di Si Kai Wei Pharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2024/04/13Generic · Class 3 Fluocinolone Acetonide,Hydroquinone And Tretinoin CreamCYHL2400075 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2024/04/13Generic · Class 3 Mannitol-S InjectionCYHL2400074 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2024/04/13New drug · Class 1 T3011疱疹病毒注射液 · No verified English nameCXSL2400230 Suzhou Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2024/04/13New drug · Class 1 T3011疱疹病毒注射液 · No verified English nameCXSL2400229 Suzhou Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2024/04/13New drug · Class 1 SGB-9768注射液 · No verified English nameCXHL2400373 Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized
2024/04/13New drug · Class 1 PZH2113 胶囊 · No verified English nameCXHL2400372 Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized
2024/04/13New drug · Class 1 PZH2113 胶囊 · No verified English nameCXHL2400371 Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized
2024/04/13New drug · Class 1 JNJ-88998377口服片 · No verified English nameCXHL2400370 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2024/04/13New drug · Class 1 JNJ-88998377口服片 · No verified English nameCXHL2400369 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2024/04/13New drug · Class 1 JNJ-88998377口服片 · No verified English nameCXHL2400368 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2024/04/13New drug · Class 2.2 LN2227 · No verified English nameCXHL2400367 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/04/13New drug · Class 1 NS-136片 · No verified English nameCXHL2400366 Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/04/13New drug · Class 1 NS-136片 · No verified English nameCXHL2400365 Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized
2024/04/12Import · Class 3.1 注射用罗特西普 · No verified English nameJXSS2400036 Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/12Import · Class 3.1 注射用罗特西普 · No verified English nameJXSS2400035 Celgene Corporation a Bristol-Myers Squibb Company; Patheon Italia S.p.A.; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/12Generic · Class 3 水合氯醛灌肠剂 · No verified English nameCYHS2401094 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2024/04/12Generic · Class 3 Ebastine Oral SolutionCYHS2401093 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2024/04/12Generic · Class 3 Levofloxacin InjectionCYHS2401087 Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized
2024/04/12New drug · Class 3.3 Sabin株脊髓灰质炎灭活疫苗(Vero细胞) · No verified English nameCXSS2400041 Beijing Min Hai Bio Technology Co., Ltd. romanized
2024/04/12New drug · Class 1.3 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2400228 Chengdu Hua Ren Kang Bio Technology Co., Ltd. romanized; Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902注射液 · No verified English nameCXSL2400227 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902滴眼液 · No verified English nameCXSL2400226 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902滴眼液 · No verified English nameCXSL2400225 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 STSP-0902滴眼液 · No verified English nameCXSL2400224 Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized
2024/04/12New drug · Class 1 GH21胶囊 · No verified English nameCXHL2400364 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/04/12New drug · Class 1 GH21胶囊 · No verified English nameCXHL2400363 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2024/04/12New drug · Class 1 D-1553片 · No verified English nameCXHL2400362 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2024/04/12New drug · Class 1 WD-890片 · No verified English nameCXHL2400361 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized

80 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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