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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 251 drug applications between 28 March 2023 and 3 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 37 drug names.

2023/03/28 – 2023/04/03

Period
2023/03/28 to 2023/04/03, 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
251
Drugs with new generic filings (by drug name, de-duplicated)
37
Accepted this week, now under review
2

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

251filings, 48 of them generic

By application type

Application typeFilings
Supplement129
Generic48
New drug30
Import26
Import re-registration11
Unspecified5
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug178
TCM39
Therapeutic biologic26
Prophylactic biologic8

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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sildenafil Citrate Tablets3112
2Diprophylline Injection227
3Pranoprofen Eye Drops227
4聚乙二醇钠钾散 · No verified English name223
5Linaclotide Capsules2113
6Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2123
7Trimetazidine Dihydrochloride Tablets210
8Ondansetron Hydrochloride Tablets216
9苯磺酸左氨氯地平片 · No verified English name2145
10Dapagliflozin Tablets2184

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

150 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Xiang Cao Tang Pharma Co., Ltd. romanized16150
2Eli Lilly and Company610
3Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized520
4Celgene Corporation510
5Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized420
6Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized420
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.422
8Chongqing Rui En Pharmaceuticals Co., Ltd. romanized420
9Pfizer Europe MA EEIG410
10Roche Pharma (Schweiz) AG410

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

62 this week

AcceptedDrugApplicants
2023/04/03Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300951 Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2023/04/03Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300950 Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2023/04/03New drug · Class 1 TQH2929注射液 · No verified English nameCXSL2300224 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300032 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300031 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300030 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Import · Class 2.4 甲苯磺酸他拉唑帕利胶囊 · No verified English nameJXHS2300029 Pfizer Europe MA EEIG; Excella GmbH & Co. KG; Pfizer Investment CO. Ltd.
2023/04/01Generic · Class 3 Pirfenidone TabletsCYHS2300947 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
2023/04/01Generic · Class 3 Carbocisteine Oral SolutionCYHS2300946 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/04/01Generic · Class 3 去氧肾上腺素酮咯酸溶液 · No verified English nameCYHL2300043 Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized
2023/04/01New drug · Class 1.1 安体威颗粒 · No verified English nameCXZL2300025 Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized
2023/04/01New drug · Class 1 SYH2051片 · No verified English nameCXHL2300351 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/04/01New drug · Class 1 SYH2051片 · No verified English nameCXHL2300350 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/04/01New drug · Class 1 JAB-26766片 · No verified English nameCXHL2300349 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2023/04/01New drug · Class 1 JAB-26766片 · No verified English nameCXHL2300348 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2023/04/01New drug · Class 1 ONC201胶囊 · No verified English nameCXHL2300347 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2023/03/31Import · Class 1 AMG 509 · No verified English nameJXSL2300063 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2023/03/31Import · Class 1 ASP1570片 · No verified English nameJXHL2300074 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2023/03/31Import · Class 1 ASP1570片 · No verified English nameJXHL2300073 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2023/03/31Generic · Class 3 Diprophylline InjectionCYHS2300943 Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2023/03/31Generic · Class 3 Diprophylline InjectionCYHS2300942 Anhui Chang Jiang Pharma Co., Ltd. romanized; Anhui Heng Xing Pharmaceutical Co., Ltd. romanized
2023/03/31Generic · Class 3 Pregabalin Oral SolutionCYHS2300936 Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jiu Long Pharmaceutical Co., Ltd. romanized
2023/03/31Generic · Class 3 Pimavanserin Tartrate CapsulesCYHL2300042 Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized
2023/03/31New drug · Class 1.1 芎芍止痛颗粒 · No verified English nameCXZL2300024 Guangdong Kai Zhong Bio Technology Co., Ltd. romanized
2023/03/31New drug · Class 1 SIM1811-03注射液 · No verified English nameCXSL2300223 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized
2023/03/31New drug · Class 1 SHR8554注射液 · No verified English nameCXHL2300346 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/31New drug · Class 1 SHR8554注射液 · No verified English nameCXHL2300345 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/31New drug · Class 2.2; 2.4 美洛昔康混悬注射液 · No verified English nameCXHL2300344 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/03/31New drug · Class 1 注射用甲磺酸普依司他 · No verified English nameCXHL2300343 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/31New drug · Class 1 注射用甲磺酸普依司他 · No verified English nameCXHL2300342 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized

32 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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