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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 621 drug applications between 25 September 2024 and 1 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 192, covering 129 drug names.

2024/09/25 – 2024/10/01

Period
2024/09/25 to 2024/10/01, 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
621
Drugs with new generic filings (by drug name, de-duplicated)
129
Accepted this week, now under review
13

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

621filings, 192 of them generic

By application type

Application typeFilings
Supplement241
Generic192
New drug104
Import44
Unspecified28
Import re-registration12

By drug type

Drug typeFilings
Chemical drug407
TCM95
Therapeutic biologic88
Biologic20
Prophylactic biologic11

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

129 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Fentanyl Citrate Buccal Tablets610
2Cefoperazone Sodium and Sulbactam Sodium for Injection6114
3Vonoprazan Fumarate Tablets4260
4Brexpiprazole Tablets4231
5Gadobutrol Injection418
6Polymyxin B sulfate for Injection336
7Propafenone Hydrochloride Injection326
8Dapagliflozin Tablets3284
9Carbamazepine Sustained-Release Tablets(II)310
10Brexpiprazole Orally Disintegrating Tablets3110

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

365 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1030
2Novo Nordisk A/S950
3AstraZeneca AB940
4Amgen Inc.920
5Yi Chang Ren Fu Pharma Co., Ltd. romanized929
6Janssen-Cilag International NV730
7Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized730
8Boehringer Ingelheim International GmbH710
9Zhejiang Wo Wu Bio Technology Co., Ltd. romanized710
10Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized660

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

232 this week

AcceptedDrugApplicants
2024/10/01Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2403329 Chengdu Jun He Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2024/10/01Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2403328 Chengdu Jun He Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2024/10/01New drug · Class 3.2 流感病毒亚单位疫苗 · No verified English nameCXSS2400107 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized
2024/10/01New drug · Class 1 CA1257胶囊 · No verified English nameCXHL2401034 Nanjing Zhong Ao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized
2024/10/01New drug · Class 1 CA1257胶囊 · No verified English nameCXHL2401033 Nanjing Zhong Ao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized
2024/10/01New drug · Class 1 CA1257胶囊 · No verified English nameCXHL2401032 Nanjing Zhong Ao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized
2024/09/30Import · Class 2.2 Dostarlimab注射液 · No verified English nameJXSL2400189 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/09/30Import · Class 1 Belrestotug注射液 · No verified English nameJXSL2400188 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Company Limited
2024/09/30Import · Class 1 MEDI5752 · No verified English nameJXSL2400187 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/09/30Import · Class 1 DD01注射液 · No verified English nameJXHL2400241 Neuraly Inc.; SHENZHEN SALUBRIS PHARMACEUTICALS CO. LTD.
2024/09/30Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2403327 Jiangsu Hui Ju Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Acetylcysteine TabletsCYHS2403323 Beijing Foyou Pharma CO.,LTD
2024/09/30Generic · Class 3 Bilastine Oral SolutionCYHS2403320 Hefei Hua Wei Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2403319 Beijing SL Pharmaceutical Co., Ltd.
2024/09/30Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2403318 Beijing SL Pharmaceutical Co., Ltd.
2024/09/30Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2403313 Zai Wei Pharma (Hainan) Co., Ltd. romanized; Hainan Tong Yong San Yang Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Isoniazid InjectionCYHS2403311 Hebei Sai Pu Yi Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2024/09/30Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2403306 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2403305 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Erythromycin Lactobionate for InjectionCYHS2403304 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2403302 Yue Kang Pharma Group Co., Ltd. romanized
2024/09/30Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2403301 Guangdong Nan Guo Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2403300 Chengdu Ming De Zhi Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2024/09/30Generic · Class 3 盐酸羟甲唑啉滴鼻液 · No verified English nameCYHS2403299 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Nanjing Hai Jing Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Acetazolamide Extended-release CapsulesCYHS2403298 Henan Zhong Shuai Pharmaceuticals Technology Co., Ltd. romanized; Henan Zhong Shuai Pharma Co., Ltd. romanized
2024/09/30Generic · Class 3 Landiolol Hydrochloride for InjectionCYHL2400199 Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized
2024/09/30New drug · Class 1.1 连花御屏颗粒 · No verified English nameCXZL2400063 Beijing Yi Ling Pharma Co., Ltd. romanized
2024/09/30New drug · Class 1.1 藤参降压颗粒 · No verified English nameCXZL2400062 Shandong Gu Jin Zhong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Zhong Pharmaceuticals University Fu Shu Hospital romanized
2024/09/30New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2400106 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2024/09/30New drug · Class 2.2 培集成干扰素α-2注射液 · No verified English nameCXSS2400105 Beijing Kai Yin Technology Co., Ltd. romanized

202 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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