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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 292 drug applications between 19 July 2023 and 25 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 42 drug names.

2023/07/19 – 2023/07/25

Period
2023/07/19 to 2023/07/25, 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
292
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
1

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

292filings, 53 of them generic

By application type

Application typeFilings
Supplement149
Generic53
New drug53
Import24
Unspecified8
Import re-registration5

By drug type

Drug typeFilings
Chemical drug170
TCM61
Therapeutic biologic55
Prophylactic biologic4
Biologic2

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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ceftazidime And Avibactam Sodium For Injection2212
2Roxatidine Acetate Hydrochloride For Injection225
3Ethyl Iosapentate Capsules2127
4Tacrolimus Sustained-release Capsules216
5Piracetam Injection219
6Vonoprazan Fumarate Tablets2160
7Pravastatin Sodium Tablets212
8注射用头孢唑肟钠 · No verified English name214
9Minoxidil Liniment2152
10米诺地尔泡沫剂 · 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

173 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan He Li Xin Jian Pharma Co., Ltd. romanized28270
2Guizhou Tian Di Pharma Co., Ltd. romanized1130
3Chengdu Di Yi Pharmaceutical Co., Ltd. romanized731
4Takeda Development Center Americas Inc.520
5Hainan Tong Yong San Yang Pharma Co., Ltd. romanized510
6Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized430
7Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized430
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
9Bristol-Myers Squibb Company410
10Novo Nordisk A/S410

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

91 this week

AcceptedDrugApplicants
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300063 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300062 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300061 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用培图罗凝血素α · No verified English nameJXSS2300060 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2023/07/25Import · Class 3.1 注射用重组人促卵泡黄体激素α · No verified English nameJXSS2300059 Merck Europe B.V.; Merck Serono S.A. Succursale d'Aubonne; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/07/25Import · Class 1 HS-20106注射液 · No verified English nameJXSL2300139 Keros Therapeutics Inc.; Shanghai Hansoh Biomedical Co. Ltd
2023/07/25Generic · Class 3 Sodium Bicarbonate InjectionCYHS2301989 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/07/25Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2301988 Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2023/07/25Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2301984 Chengdu Brilliant Pharmaceutical Co., Ltd.
2023/07/25Generic · Class 3 头孢地尼干混悬剂 · No verified English nameCYHS2301983 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/07/25Generic · Class 3 无水乙醇注射液 · No verified English nameCYHS2301982 Beijing Tong Ji Da Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/07/25Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2301977 Zhengzhou Wei Xian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2023/07/25Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2301976 Anhui Chang Jiang Pharma Co., Ltd. romanized
2023/07/25New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2300015 Wuhan Kang Le Pharma Co., Ltd. romanized
2023/07/25New drug · Class 2.2 聚乙二醇重组人生长激素注射液 · No verified English nameCXSS2300057 Changchun Jin Sai Pharma Co., Ltd. romanized
2023/07/25New drug · Class 1 SIM0348注射液 · No verified English nameCXSL2300513 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2023/07/25New drug · Class 1 注射用SIM0237 · No verified English nameCXSL2300512 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2023/07/25New drug · Class 1 AK120注射液 · No verified English nameCXSL2300511 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2023/07/25New drug · Class 1 重组人源化抗TrkA单克隆抗体注射液 · No verified English nameCXSL2300510 Xi Yuan An Jian Pharmaceuticals (Shanghai) Co., Ltd. romanized
2023/07/25New drug · Class 1 VUM02注射液 · No verified English nameCXSL2300509 Wuhan Guang Gu Zhong Yuan Pharma Co., Ltd. romanized
2023/07/25New drug · Class 2.2 盐酸奥洛他定口服溶液 · No verified English nameCXHL2300816 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/07/25New drug · Class 2.2 盐酸奥洛他定口服溶液 · No verified English nameCXHL2300815 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2023/07/25New drug · Class 2.2 西格列汀二甲双胍控释片 · No verified English nameCXHL2300814 Sai Le Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/07/25New drug · Class 2.2 西格列汀二甲双胍控释片 · No verified English nameCXHL2300813 Sai Le Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/07/25New drug · Class 2.2 布瑞哌唑长效注射剂 · No verified English nameCXHL2300812 Sichuan Kelun Pharmaceutical Co., Ltd.
2023/07/25New drug · Class 1 RSS0393软膏 · No verified English nameCXHL2300811 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2023/07/25New drug · Class 1 RSS0393软膏 · No verified English nameCXHL2300810 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2023/07/24New drug · Class 1 注射用LBL-024 · No verified English nameCXSL2300508 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2023/07/22Import · Class 1 Bemarituzumab注射液 · No verified English nameJXSL2300138 Amgen Inc.; Zai Lab (Shanghai) CO. Ltd.
2023/07/22Import · Class 1 Cetrelimab注射液 · No verified English nameJXSL2300137 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.

61 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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