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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 309 drug applications between 1 March 2024 and 7 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 60 drug names.

2024/03/01 – 2024/03/07

Period
2024/03/01 to 2024/03/07, 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
309
Drugs with new generic filings (by drug name, de-duplicated)
60
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

309filings, 82 of them generic

By application type

Application typeFilings
Supplement159
Generic82
New drug31
Import19
Unspecified10
Import re-registration8

By drug type

Drug typeFilings
Chemical drug196
TCM70
Therapeutic biologic42
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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diprophylline Injection447
2Vonoprazan Fumarate Tablets4260
3Brivaracetam Tablets3119
4Neostigmine Methylsulfate Injection314
5Glucosamine Sulfate Capsules2251
6Lactulose Oral Solution2134
7Ozagrel Sodium Injection213
8帕立骨化醇软胶囊 · No verified English name210
9Sildenafil Citrate Tablets2112
10Vortioxetine Hydrobromide Tablets2110

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

184 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized23170
2Sichuan Guang Da Pharmaceutical Co., Ltd. romanized1090
3Takeda Manufacturing Austria AG620
4EUROAPI Germany GmbH550
5Sichuan Kelun Pharmaceutical Co., Ltd.525
6Jilin Sheng Li Sheng Pharmaceutical Co., Ltd. romanized440
7Guo Yao Group Guizhou Biopharmaceutical Co., Ltd. romanized420
8Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized420
9H. Lundbeck A/S410
10AstraZeneca AB330

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

87 this week

AcceptedDrugApplicants
2024/03/07Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2400793 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2024/03/07Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2400788 Anhui Xin Shi Ji Pharma Co., Ltd. romanized; Ping Guang Pharmaceutical Co., Ltd. romanized
2024/03/07Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2400786 Hebei Long Hai Pharma Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/03/07New drug · Class 1.1 母苏颗粒 · No verified English nameCXZL2400013 Rui Yang Pharmaceutical Co., Ltd. romanized
2024/03/07New drug · Class 1 SYS6002 · No verified English nameCXSL2400174 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/03/07New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2400173 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/03/07New drug · Class 1 HRS9531片 · No verified English nameCXHL2400251 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/07New drug · Class 1 HRS9531片 · No verified English nameCXHL2400250 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/07New drug · Class 1 HRS9531片 · No verified English nameCXHL2400249 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/07New drug · Class 1 SC0245片 · No verified English nameCXHL2400248 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2024/03/07New drug · Class 1 SC0245片 · No verified English nameCXHL2400247 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2024/03/07New drug · Class 1 KX-826酊 · No verified English nameCXHL2400246 Suzhou Kai Xi Pharmaceuticals Co., Ltd. romanized
2024/03/07New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2400245 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/03/07New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2400244 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/03/07New drug · Class 1 DGPR1008注射液 · No verified English nameCXHL2400243 Xin Dou Bio Technology (Suzhou) Co., Ltd. romanized
2024/03/06Import · Class 1 AZD2936 · No verified English nameJXSL2400057 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/06Import · Class 1 Vixarelimab 注射液 · No verified English nameJXSL2400056 Genentech Inc.
2024/03/06Import · Class 1 Vorasidenib片 · No verified English nameJXHL2400061 Institut de Recherches Internationales Servier
2024/03/06Import · Class 1 Vorasidenib片 · No verified English nameJXHL2400060 Institut de Recherches Internationales Servier
2024/03/06Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400780 Fujian Tian Quan Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/03/06Generic · Class 3 Potassium Chloride GranulesCYHS2400778 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/03/06Generic · Class 3 Ozagrel Sodium InjectionCYHS2400776 Chi Feng Jing Fang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/03/06Generic · Class 3 Ozagrel Sodium InjectionCYHS2400775 Chi Feng Jing Fang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/03/06Generic · Class 3 帕立骨化醇软胶囊 · No verified English nameCYHS2400772 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/06Generic · Class 3 帕立骨化醇软胶囊 · No verified English nameCYHS2400770 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/03/06Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2400056 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
2024/03/06Generic · Class 3 Brivaracetam TabletsCYHL2400055 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/03/06Generic · Class 3 Brivaracetam TabletsCYHL2400054 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/03/06Generic · Class 3 Brivaracetam TabletsCYHL2400053 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/03/06New drug · Class 1 注射用SKB501 · No verified English nameCXSL2400172 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized

57 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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