YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 322 drug applications between 18 January 2024 and 24 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 67 drug names.

2024/01/18 – 2024/01/24

Period
2024/01/18 to 2024/01/24, 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
322
Drugs with new generic filings (by drug name, de-duplicated)
67
Accepted this week, now under review
2

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

322filings, 88 of them generic

By application type

Application typeFilings
Supplement144
Generic88
New drug54
Import22
Import re-registration9
Unspecified4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug213
TCM53
Therapeutic biologic50
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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piracetam Injection429
2Calcium Folinate Injection314
3Diprophylline Injection227
4Roxadustat Capsules2217
5Lactulose Oral Solution2134
6Crizotinib Capsules217
7复方聚乙二醇电解质散(Ⅱ) · No verified English name214
8Amisulpride Injection211
9Sacubitril Valsartan Sodium Tablets2170
10Degarelix Acetate for Injection210

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Gansu Yong He Tang Pharma Co., Ltd. romanized16160
2Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized1090
3Boehringer Ingelheim International GmbH1040
4Jin He Zang Yao Co., Ltd. romanized770
5AstraZeneca AB740
6Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized650
7Amgen Inc.620
8Jilin Wu Tai Gan Kang Pharma Co., Ltd. romanized550
9Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized440

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

117 this week

AcceptedDrugApplicants
2024/01/24Import · Class 1 Tarlatamab · No verified English nameJXSL2400027 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/01/24Import · Class 1 Tarlatamab · No verified English nameJXSL2400026 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/01/24Import · Class 1 Tarlatamab · No verified English nameJXSL2400025 Amgen Inc.; BeiGene (Beijing) Co. Ltd
2024/01/24Import · Class 1 JK07注射液 · No verified English nameJXSL2400024 Salubris Biotherapeutics Inc.; Shenzhen Salubris Pharmaceuticals Co. Ltd.
2024/01/24Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2400023 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2024/01/24Generic · Class 3 Piracetam InjectionCYHS2400332 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/01/24Generic · Class 3 Piracetam InjectionCYHS2400331 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/01/24Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2400325 Ao Mei Pharmaceutical (Hainan) Co., Ltd. romanized
2024/01/24Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHS2400324 Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/01/24Generic · Class 3 Multiple Electrolytes and Sodium Acetate InjectionCYHS2400319 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/01/24Generic · Class 3 Indobufen TabletsCYHS2400317 Jin Hong Pharma Co., Ltd. romanized
2024/01/24Generic · Class 3 Famotidine InjectionCYHS2400316 Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized; Dan Dong Yi Chuang Pharma Co., Ltd. romanized
2024/01/24Generic · Class 3 Diprophylline InjectionCYHS2400311 Hunan Er Kang Pharmaceutical Co., Ltd. romanized
2024/01/24Generic · Class 3 Amisulpride InjectionCYHL2400023 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized
2024/01/24Generic · Class 3 Amisulpride InjectionCYHL2400022 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized
2024/01/24New drug · Class 3.1 一贯煎颗粒 · No verified English nameCXZS2400005 Jilin Ao Dong Tao Nan Pharma Co., Ltd. romanized
2024/01/24New drug · Class 3.4 人纤维蛋白粘合剂 · No verified English nameCXSL2400057 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2024/01/24New drug · Class 1 PT217 · No verified English nameCXSL2400056 Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized
2024/01/24New drug · Class 1 注射用MK-2870 · No verified English nameCXSL2400055 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2024/01/24New drug · Class 2.2 盐酸替扎尼定口服溶液 · No verified English nameCXHS2400006 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2024/01/24New drug · Class 2.2 盐酸替扎尼定口服溶液 · No verified English nameCXHS2400005 Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized
2024/01/24New drug · Class 2.2; 2.4 硫酸依替米星雾化吸入溶液 · No verified English nameCXHL2400100 Wuxi Ji Yu Shan He Pharma Co., Ltd. romanized
2024/01/23Import · Class 2.2 注射用替奈普酶 · No verified English nameJXSS2400001 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/01/23Import · Class 1 阿塞西普 · No verified English nameJXSL2400022 Vera Therapeutics Inc.; Tianjin Happy Life Technology Co. Ltd.
2024/01/23Import · Class 1 AMG 193 · No verified English nameJXHL2400023 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/01/23Import · Class 1 AMG 193 · No verified English nameJXHL2400022 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/01/23Import · Class 1 AMG 193 · No verified English nameJXHL2400021 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/01/23Generic · Class 3 Bumetanide InjectionCYHS2400308 Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/01/23Generic · Class 3 Sodium Thiosulfate InjectionCYHS2400306 Nanjing Hai Chen Pharma Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2024/01/23Generic · Class 3 Urapidil Sustained-release CapsulesCYHS2400304 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

87 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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