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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 387 drug applications between 8 November 2025 and 14 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 56 drug names.

2025/11/08 – 2025/11/14

Period
2025/11/08 to 2025/11/14, 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
387
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
83

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

387filings, 79 of them generic

By application type

Application typeFilings
Supplement202
Generic79
New drug64
Import25
Import re-registration11
Unspecified6

By drug type

Drug typeFilings
Chemical drug234
TCM111
Therapeutic biologic34
Prophylactic biologic7
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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Finerenone Tablets3269
2奥氮平萨米多芬片 · No verified English name310
3Brexpiprazole Tablets3131
4二甲硅油乳剂 · No verified English name2214
5Edaravone and Dexborneol Concentrated Solution for Injection2234
6瑞维那新吸入溶液 · No verified English name2253
7Iguratimod Tablets2223
8Acetylcysteine Oral Solution2111
9依伏卡塞片 · No verified English name219
10利伐沙班干混悬剂 · No verified English name212

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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Takeda Development Center Americas Inc.830
2Sichuan Shu Zhong Pharma Co., Ltd. romanized770
3Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
4Boehringer Ingelheim International GmbH730
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized730
6Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized660
7Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized660
8Bracco Imaging S.P.A.610
9Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized550
10AstraZeneca AB540

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

114 this week

AcceptedDrugApplicants
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
2025/11/14New drug · Class 2.2; 2.4 SQ-24071滴眼液 · No verified English nameCXHL2501261 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2025/11/14New drug · Class 2.2; 2.4 SQ-24071滴眼液 · No verified English nameCXHL2501260 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2025/11/14New drug · Class 2.2; 2.4 SQ-24071滴眼液 · No verified English nameCXHL2501259 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2025/11/14New drug · Class 2.2; 2.4 SQ-24071滴眼液 · No verified English nameCXHL2501258 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2025/11/14New drug · Class 1 RTX-117片 · No verified English nameCXHL2501255 Xi Li Technology (Shenzhen) Co., Ltd. romanized
2025/11/14New drug · Class 1 RTX-117片 · No verified English nameCXHL2501254 Xi Li Technology (Shenzhen) Co., Ltd. romanized
2025/11/14New drug · Class 2.2 HKG-456 · No verified English nameCXHL2501253 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized
2025/11/14New drug · Class 1 GH21胶囊 · No verified English nameCXHL2501252 Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized
2025/11/13Import · Class 2.2 多奈单抗注射液 · No verified English nameJXSL2500221 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2500131 Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2500130 Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/11/13Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2500129 Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd.

84 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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