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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 211 drug applications between 2 April 2024 and 8 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 41 drug names.

2024/04/02 – 2024/04/08

Period
2024/04/02 to 2024/04/08, 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
211
Drugs with new generic filings (by drug name, de-duplicated)
41
Accepted this week, now under review
4

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

211filings, 48 of them generic

By application type

Application typeFilings
Supplement100
Generic48
New drug36
Import18
Unspecified5
Import re-registration4

By drug type

Drug typeFilings
Chemical drug131
TCM40
Therapeutic biologic39
Biologic1

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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection2213
2腺苷钴胺胶囊 · No verified English name228
3Palbociclib Capsules210
4Deferasirox Tablets213
5Olmesartan Medoxomil Orally Disintegrating Tablets210
6Atosiban Acetate Injection212
7Febuxostat Tablets2112
8Lactated Ringer's Injection115
9二甲双胍恩格列净片(Ⅰ) · No verified English name117
10依托咪酯中/长链脂肪乳注射液 · No verified English name113

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

139 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chen Huan Pharmaceuticals Group Co., Ltd. romanized550
2Tong Hua Zheng Yuan Pharma Co., Ltd. romanized530
3Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized444
4Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
5Eli Lilly and Company420
6Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410
7Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized410
8Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized410
9Shandong Er Ye Pharmaceutical Co., Ltd. romanized410
10Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized410

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

73 this week

AcceptedDrugApplicants
2024/04/08Import · Class 1 BAY 3018250 · No verified English nameJXSL2400068 Bayer AG; Bayer Healthcare Company Ltd.
2024/04/08Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400087 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/04/08Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400086 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/04/08Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2401032 Hunan Hai Shi Biopharmaceuticals Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2024/04/08Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2401029 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Guangdong An Nuo Pharma Co., Ltd. romanized
2024/04/08Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2401025 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2024/04/08Generic · Class 3 Olanzapine for InjectionCYHS2401024 Qilu Pharmaceutical Co., Ltd.
2024/04/08Generic · Class 3 腺苷钴胺胶囊 · No verified English nameCYHS2401022 NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2024/04/08Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2401018 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2024/04/08Generic · Class 3 Potassium Phosphates InjectionCYHS2401015 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/04/08New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSS2400038 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/04/08New drug · Class 1 注射用人脐带间充质干细胞 · No verified English nameCXSL2400212 Ai Er Pu Zai Sheng Yi Xue Technology (Shenzhen) Co., Ltd. romanized
2024/04/08New drug · Class 2.2 水合氯醛糖浆 · No verified English nameCXHS2400025 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2024/04/08New drug · Class 1 RS-C1001片 · No verified English nameCXHL2400340 Qingdao Rui Sen Bio Technology Co., Ltd. romanized
2024/04/08New drug · Class 1 RS-C1001片 · No verified English nameCXHL2400339 Qingdao Rui Sen Bio Technology Co., Ltd. romanized
2024/04/08New drug · Class 1 KY386注射用浓溶液 · No verified English nameCXHL2400338 Shenzhen Kai Yue Sheng Ming Technology Co., Ltd. romanized
2024/04/07New drug · Class 1.1 益气消瘤颗粒 · No verified English nameCXZL2400019 Guangdong Fang Sheng Rong Da Pharma Co., Ltd. romanized
2024/04/04Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2400034 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2024/04/04Import · Class 2.2 司美格鲁肽注射液 · No verified English nameJXHL2400085 Dr. Reddy's Laboratories Limited; Dr. Reddy's (Beijing) Pharmaceutical Co. Ltd.
2024/04/04Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2400084 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/04Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2400083 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/04Import · Class 1 Golcadomide胶囊 · No verified English nameJXHL2400082 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2024/04/04Import · Class 1 BAY 2862789口服溶液 · No verified English nameJXHL2400081 Bayer AG; Bayer Healthcare Company Ltd.
2024/04/04Generic · Class 3 Deferasirox TabletsCYHS2401014 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Suzhou Erye Pharmaceutical Co., Ltd
2024/04/04Generic · Class 3 Deferasirox TabletsCYHS2401013 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Suzhou Erye Pharmaceutical Co., Ltd
2024/04/04Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2401011 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/04/04Generic · Class 3 Bumetanide InjectionCYHS2401010 Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/04/04New drug · Class 1.1 龙七胶囊 · No verified English nameCXZS2400011 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/04/04New drug · Class 2.3 丹红化瘀口服液 · No verified English nameCXZL2400018 Guangzhou Bai Yun Shan He Ji Huang Pu Zhong Yao Co., Ltd. romanized
2024/04/04New drug · Class 1 注射用RAB001 · No verified English nameCXHL2400337 Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized

43 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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