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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 239 drug applications between 10 March 2024 and 16 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 42 drug names.

2024/03/10 – 2024/03/16

Period
2024/03/10 to 2024/03/16, 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
239
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
0

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

239filings, 57 of them generic

By application type

Application typeFilings
Supplement105
Generic57
New drug43
Import re-registration14
Import12
Unspecified8

By drug type

Drug typeFilings
Chemical drug162
TCM35
Therapeutic biologic31
Biologic7
Prophylactic biologic4

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
1Amlodipine Besylate Tablets428
2Methotrexate Injection3211
3Tadalafil Tablets3123
4Ethyl Iosapentate Capsules2127
5Carbidopa and Levodopa Sustained-release Tablets212
6Perampanel Tablets212
7Cefditoren Pivoxil Granules2118
8Montelukast Sodium Chewable Tablets214
9小儿复方氨基酸注射液(19AA-I) · No verified English name212
10Lasmiditan Tablets210

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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Shuang He Hua Li Pharma Co., Ltd. romanized1430
2Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized990
3Hui Rui Pharma (Hubei) Co., Ltd. romanized760
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.642
5Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized420
6Dr. Falk Pharma GmbH410
7Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized410
8Hainan Ling Kang Pharmaceutical Co., Ltd. romanized410
9Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410
10Boehringer Ingelheim International GmbH330

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

67 this week

AcceptedDrugApplicants
2024/03/16Import · Class 1 注射用Datopotamab Deruxtecan · No verified English nameJXSS2400026 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/03/16Import · Class 1 ABBV-400注射用粉末 · No verified English nameJXSL2400060 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400026 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400025 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400024 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400023 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 1 注射用苏维西塔单抗 · No verified English nameCXSS2400022 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized
2024/03/16New drug · Class 1 BAT6005注射液 · No verified English nameCXSL2400189 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/16New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2400188 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/16New drug · Class 1.2 呼吸道合胞病毒IN006二价mRNA疫苗 · No verified English nameCXSL2400187 Shenzhen Shen Xin Bio Technology Co., Ltd. romanized
2024/03/16New drug · Class 1 ABP1618片 · No verified English nameCXHL2400285 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/03/16New drug · Class 1 ABP1618片 · No verified English nameCXHL2400284 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/03/15Import · Class 2.2; 2.4 TAR-210 · No verified English nameJXHL2400065 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/03/15Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2400064 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/15Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2400063 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/15Generic · Class 3 Atropine Sulfate InjectionCYHS2400853 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2024/03/15Generic · Class 3 普仑司特干糖浆 · No verified English nameCYHS2400849 Ji Chuan Pharma Group Co., Ltd. romanized
2024/03/15Generic · Class 3 Cimetidine InjectionCYHS2400845 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/03/15Generic · Class 3 复方聚乙二醇电解质散(儿童型) · No verified English nameCYHS2400838 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/03/15New drug · Class 1 SHR-4849注射液 · No verified English nameCXSL2400186 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/03/15New drug · Class 1 FC084CSA片 · No verified English nameCXHL2400283 Zhong Shan Yi Nuo Wei Shen Xin Yao Research and Development Co., Ltd. romanized
2024/03/15New drug · Class 1 FC084CSA片 · No verified English nameCXHL2400282 Zhong Shan Yi Nuo Wei Shen Xin Yao Research and Development Co., Ltd. romanized
2024/03/14Import · Class 1 BI 1839100 片 · No verified English nameJXHL2400062 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2024/03/14Generic · Class 3 溴吡斯的明缓释片 · No verified English nameCYHS2400832 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2024/03/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2400830 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/03/14Generic · Class 3 小儿复方氨基酸注射液(19AA-I) · No verified English nameCYHS2400829 Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2024/03/14Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400827 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/03/14Generic · Class 3 盐酸麻黄碱注射液 · No verified English nameCYHS2400825 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2024/03/14Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2400824 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2024/03/14New drug · Class 1.1 温肺定喘颗粒 · No verified English nameCXZL2400015 Shandong Kang Zhong Hong Pharmaceuticals Technology Kai Fa Co., Ltd. romanized

37 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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