YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 393 drug applications between 8 March 2025 and 14 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 80 drug names.

2025/03/08 – 2025/03/14

Period
2025/03/08 to 2025/03/14, 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
393
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
24

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

393filings, 119 of them generic

By application type

Application typeFilings
Supplement166
Generic119
New drug41
Import re-registration25
Import22
Unspecified20

By drug type

Drug typeFilings
Chemical drug319
TCM36
Therapeutic biologic32
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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets9470
2地氯雷他定口服溶液 · No verified English name4226
3Mivacurium Chloride Injection423
4Dapagliflozin Tablets4284
5Lactulose Oral Solution3234
6甲氧氯普胺片 · No verified English name323
7Riociguat Tablets314
8Levofloxacin and Sodium Chloride Injection3114
9Bisoprolol Fumarate and Amlodipine Besylate Tablets229
10Glucosamine Sulfate Capsules2251

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

221 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized18171
2Bracco Imaging S.P.A.1310
3Fresenius Kabi Deutschland GmbH1220
4Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized660
5Bayer AG630
6Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized630
7Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
8AstraZeneca AB530
9Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized522
10Hubei Wu Shi Pharma Co., Ltd. romanized434

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

93 this week

AcceptedDrugApplicants
2025/03/14Import · Class 1 TQJ230注射液 · No verified English nameJXHL2500044 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2025/03/14Import · Class 1 ELVN-001胶囊 · No verified English nameJXHL2500043 Enliven Therapeutics Inc.; R&G PharmaStudies Co. Ltd.
2025/03/14Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2501064 Shandong Yi Kang Pharma Co., Ltd. romanized
2025/03/14Generic · Class 3 Famotidine InjectionCYHS2501060 Anhui Mei Lai Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/03/14Generic · Class 3 甲氧氯普胺片 · No verified English nameCYHS2501059 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/03/14Generic · Class 3 Famotidine InjectionCYHS2501058 Anhui Mei Lai Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2025/03/14Generic · Class 3 Hydrotalcite SuspensionCYHS2501057 Anhui Hao Yu Biopharmaceutical Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2025/03/14Generic · Class 3 多种维生素注射液(13)(10/3) · No verified English nameCYHS2501056 Hunan Xian Shi Pharmaceutical Co., Ltd. romanized
2025/03/14Generic · Class 3 Furosemide Oral SolutionCYHS2501054 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanized
2025/03/14Generic · Class 3 Cytarabine InjectionCYHS2501052 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/03/14Generic · Class 3 Cytarabine InjectionCYHS2501051 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/03/14New drug · Class 1.1 六味地黄苷糖片 · No verified English nameCXZS2500011 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2025/03/14New drug · Class 1 SPGL008注射液 · No verified English nameCXSL2500223 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2025/03/14New drug · Class 1 HMPL-306片 · No verified English nameCXHL2500282 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/03/14New drug · Class 1 HMPL-306片 · No verified English nameCXHL2500281 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/03/14New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHL2500280 Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized
2025/03/14New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHL2500279 Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized
2025/03/14New drug · Class 2.4 Potassium Sodium Hydrogen Citrate GranulesCXHL2500278 Shenyang Xin Rui Pharmaceutical Co., Ltd. romanized
2025/03/13Import · Class 3.1 注射用维替索妥尤单抗 · No verified English nameJXSS2500023 Seagen Inc.; Baxter Oncology GmbH; Zai Lab(Shanghai) Co. Ltd
2025/03/13Import · Class 1 MK-7240注射液 · No verified English nameJXSL2500037 Merck Sharp & Dohme LLC; Name not romanized
2025/03/13Import · Class 1 SAR441566 · No verified English nameJXHL2500042 Sanofi-Aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500041 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500040 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500039 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Import · Class 1 LY3549492片 · No verified English nameJXHL2500038 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/03/13Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2501047 Anhui Chang Jiang Pharma Co., Ltd. romanized
2025/03/13Generic · Class 3 Sodium Thiosulfate InjectionCYHS2501043 Chengdu Yao Yi Li Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized
2025/03/13Generic · Class 3 Furosemide TabletsCYHS2501040 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/03/13Generic · Class 3 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2501039 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2025/03/13Generic · Class 3 碘解磷定注射液 · No verified English nameCYHS2501036 Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized

63 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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