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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 456 drug applications between 20 September 2024 and 26 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 142, covering 98 drug names.

2024/09/20 – 2024/09/26

Period
2024/09/20 to 2024/09/26, 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
456
Drugs with new generic filings (by drug name, de-duplicated)
98
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

456filings, 142 of them generic

By application type

Application typeFilings
Supplement167
Generic142
New drug74
Import37
Unspecified22
Import re-registration13
Drug-device combination1

By drug type

Drug typeFilings
Chemical drug290
Therapeutic biologic72
TCM66
Biologic19
Prophylactic biologic9

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

98 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets6231
2Fentanyl Citrate Buccal Tablets610
3Cefoperazone Sodium and Sulbactam Sodium for Injection6114
4Dapagliflozin Tablets3284
5Carbamazepine Sustained-Release Tablets(II)310
6Brexpiprazole Orally Disintegrating Tablets3110
7Amoxicillin Sodium and Sulbactam Sodium for Injection317
8Procaterol Hydrochloride Granules312
9Ethyl Iosapentate Capsules2227
10Bumetanide Injection2213

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

268 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1120
2Amgen Inc.920
3Yi Chang Ren Fu Pharma Co., Ltd. romanized929
4Guo Yao Group Kunming Xue Ye Zhi Pin Co., Ltd. romanized730
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
6Zhejiang Wo Wu Bio Technology Co., Ltd. romanized710
7Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized660
8Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized630
9Janssen-Cilag International NV620
10Baxalta Manufacturing Sàrl610

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

167 this week

AcceptedDrugApplicants
2024/09/26Import · Class 1 PF-08046047 · No verified English nameJXSL2400182 Seagen Inc.; Pfizer Investment CO. Ltd.
2024/09/26Import · Class 1 JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400181 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/09/26Import · Class 1 JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2400180 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/09/26Import · Class 1 E7386 · No verified English nameJXHL2400237 Eisai Co. Ltd.
2024/09/26Import · Class 1 E7386 · No verified English nameJXHL2400236 Eisai Co. Ltd.
2024/09/26Import · Class 1 E7386 · No verified English nameJXHL2400235 Eisai Co. Ltd.
2024/09/26Generic · Class 3 Aceclofenac TabletsCYHS2403261 Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 Minodronic acid TabletsCYHS2403258 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/09/26Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2403257 Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 Chloroprocaine Hydrochloride InjectionCYHS2403256 Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 多索茶碱口服溶液 · No verified English nameCYHS2403255 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2024/09/26Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2403251 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2403250 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 Procaterol Hydrochloride GranulesCYHS2403249 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2403244 Nanjing Si Ling Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2403243 Anhui Kang Rong Pharma Co., Ltd. romanized
2024/09/26Generic · Class 3 Bumetanide InjectionCYHS2403237 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/09/26Generic · Class 3 Calcium Polycarbophil Fine GranulesCYHS2403235 Zhejiang Zuo Li Pharma Co., Ltd. romanized
2024/09/26Generic · Class 3 Verapamil Hydrochloride InjectionCYHS2403234 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/09/26Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400195 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2024/09/26Generic · Class 3 立他司特滴眼液 · No verified English nameCYHL2400194 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2024/09/26New drug · Class 3.1 枇杷清肺颗粒 · No verified English nameCXZS2400032 Shen Wei Pharma Group Co., Ltd. romanized
2024/09/26New drug · Class 1.1 参葛颗粒 · No verified English nameCXZL2400060 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2024/09/26New drug · Class 2.2 纳基奥仑赛注射液 · No verified English nameCXSS2400104 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2024/09/26New drug · Class 1 匹康奇拜单抗注射液 · No verified English nameCXSS2400103 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized; Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/09/26New drug · Class 1 注射用HLX43 · No verified English nameCXSL2400668 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2024/09/26New drug · Class 1 VUM02注射液 · No verified English nameCXSL2400667 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2024/09/26New drug · Class 3.3 SYS6036注射液 · No verified English nameCXSL2400666 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/09/26New drug · Class 1.1 LVRNA101 · No verified English nameCXSL2400665 Zhuhai Li Fan Da Bio Technology Co., Ltd. romanized; Changchun Bai Ke Bio Technology Shareholding Company romanized
2024/09/26New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2400664 Shanghai Mai Ji Bio Technology Co., Ltd. romanized

137 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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