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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 384 drug applications between 11 November 2025 and 17 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 67, covering 50 drug names.

2025/11/11 – 2025/11/17

Period
2025/11/11 to 2025/11/17, 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
384
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
75

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

384filings, 67 of them generic

By application type

Application typeFilings
Supplement212
Generic67
New drug67
Import24
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug240
TCM106
Therapeutic biologic29
Prophylactic biologic8
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

50 drugs with new generic filings; top 10 listed

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

205 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1410
2Takeda Development Center Americas Inc.830
3Sichuan Shu Zhong Pharma Co., Ltd. romanized770
4Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
5Boehringer Ingelheim International GmbH730
6Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized660
7Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized630
8Hunan Ke Lun Pharmaceutical Co., Ltd. romanized620
9Bracco Imaging S.P.A.610
10Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized550

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

115 this week

AcceptedDrugApplicants
2025/11/17New drug · Class 1 JNJ-95597528注射液 · No verified English nameCXSL2500974 Qiang Sheng (Zhongguo) Investment Co., Ltd. romanized
2025/11/17New drug · Class 1 YKYY032注射液 · No verified English nameCXHL2501263 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2025/11/17New drug · Class 2.1; 2.4 AP-2202片 · No verified English nameCXHL2501262 Hangzhou An Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/11/15Import · Class 1 EPX-100口服溶液 · No verified English nameJXHL2500354 Epygenix Therapeutics Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd
2025/11/15Generic · Class 3 Furosemide TabletsCYHS2503971 Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
2025/11/15Generic · Class 3 Latamoxef Sodium for InjectionCYHS2503970 Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized
2025/11/15New drug · Class 1 SYS6010 · No verified English nameCXSL2500973 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/11/15New drug · Class 2.5 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2500972 Zhejiang Pu Kang Bio Technology Co., Ltd. romanized
2025/11/15New drug · Class 1 JMT108注射液 · No verified English nameCXSL2500971 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/11/15New drug · Class 1 HLX701注射液 · No verified English nameCXSL2500970 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Shi Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/11/15New drug · Class 1 ASN-8639片 · No verified English nameCXHL2501257 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2025/11/15New drug · Class 1 ASN-8639片 · No verified English nameCXHL2501256 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2025/11/14Import · Class 2.2 Mirikizumab注射液 · No verified English nameJXSL2500223 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/14Import · Class 2.2 Mirikizumab注射液 · No verified English nameJXSL2500222 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/14Import · Class 1 LY4268989胶囊 · No verified English nameJXHL2500353 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/14Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503967 Jiangxi Yuan Sheng Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/11/14Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2503966 Jiangxi Yuan Sheng Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/11/14Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2503963 Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2025/11/14Generic · Class 3 Diprophylline InjectionCYHS2503961 Da Wei (Anhui) Pharma Co., Ltd. romanized; Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized
2025/11/14Generic · Class 3 Olopatadine Hydrochloride GranulesCYHS2503958 Hainan Sai Li Ke Pharma Co., Ltd. romanized
2025/11/14Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503955 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2025/11/14New drug · Class 2.4 YFZ-003 · No verified English nameCXZL2500116 Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized
2025/11/14New drug · Class 2.4 YFZ-003 · No verified English nameCXZL2500115 Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized
2025/11/14New drug · Class 2.4 YFZ-003 · No verified English nameCXZL2500114 Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized
2025/11/14New drug · Class 2.4 YFZ-003 · No verified English nameCXZL2500113 Sichuan Kai Jing Pharmaceutical Co., Ltd. romanized
2025/11/14New drug · Class 2.2 B群脑膜炎球菌OMV疫苗 · No verified English nameCXSL2500969 Shanghai Yu Guan Bio Technology Co., Ltd. romanized
2025/11/14New drug · Class 2.2 B群脑膜炎球菌OMV疫苗 · No verified English nameCXSL2500968 Shanghai Yu Guan Bio Technology Co., Ltd. romanized
2025/11/14New drug · Class 2.2 B群脑膜炎球菌OMV疫苗 · No verified English nameCXSL2500967 Shanghai Yu Guan Bio Technology Co., Ltd. romanized
2025/11/14New drug · Class 1 IBI343 · No verified English nameCXSL2500966 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2025/11/14New drug · Class 2.2 玛舒拉沙韦干混悬剂 · No verified English nameCXHS2500136 Jiangxi Ke Rui Pharma Co., Ltd. romanized

85 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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