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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 303 drug applications between 27 March 2024 and 2 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 57 drug names.

2024/03/27 – 2024/04/02

Period
2024/03/27 to 2024/04/02, 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
303
Drugs with new generic filings (by drug name, de-duplicated)
57
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

303filings, 80 of them generic

By application type

Application typeFilings
Supplement144
Generic80
New drug36
Import26
Import re-registration10
Unspecified7

By drug type

Drug typeFilings
Chemical drug217
Therapeutic biologic43
TCM39
Biologic3
Prophylactic 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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment5352
2Bumetanide Injection4313
3Diprophylline Injection227
4Acetylcysteine Solution For Inhalation224
5Bromhexine Hydrochloride Injection228
6Tacrolimus Capsules212
7Selexipag Tablets2124
8Multiple Electrolytes and Sodium Acetate Injection214
9Olmesartan Medoxomil Orally Disintegrating Tablets210
10Levothyroxine Sodium Tablets2112

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

188 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tong Hua Zheng Yuan Pharma Co., Ltd. romanized970
2Pfizer Inc.740
3He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized620
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
5Myokardia Inc.510
6Haerbin Han Bang Medical Technology Co., Ltd. romanized510
7Jiangsu Vanguard Pharmaceutical Co., Ltd.434
8LG Chem Ltd.410
9Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410
10Shanghai Jun Shi Biopharmaceuticals Technology 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

100 this week

AcceptedDrugApplicants
2024/04/02Import · Class 1 PF-07264660注射液 · No verified English nameJXSL2400066 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/04/02Import · Class 1 PF-07275315注射液 · No verified English nameJXSL2400065 Pfizer Inc.; Pfizer Investment CO. Ltd.
2024/04/02Import · Class 1 Bomedemstat胶囊 · No verified English nameJXHL2400080 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/04/02Import · Class 1 Bomedemstat胶囊 · No verified English nameJXHL2400079 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/04/02Import · Class 1 Bomedemstat胶囊 · No verified English nameJXHL2400078 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/04/02Import · Class 1 Bomedemstat胶囊 · No verified English nameJXHL2400077 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2024/04/02Generic · Class 3 Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2400991 Jilin Sheng De Shang Pharma Co., Ltd. romanized
2024/04/02Generic · Class 3 Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2400990 Jilin Sheng De Shang Pharma Co., Ltd. romanized
2024/04/02Generic · Class 3 Bumetanide InjectionCYHS2400989 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/04/02New drug · Class 1.1 司亚丹凝胶 · No verified English nameCXZL2400017 Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2024/04/02New drug · Class 1 昂戈瑞西单抗注射液 · No verified English nameCXSS2400031 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2024/04/02New drug · Class 1 昂戈瑞西单抗注射液 · No verified English nameCXSS2400030 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2024/04/02New drug · Class 1 昂戈瑞西单抗注射液 · No verified English nameCXSS2400029 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2024/04/02New drug · Class 1 昂戈瑞西单抗注射液 · No verified English nameCXSS2400028 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2024/04/02New drug · Class 1 注射用BGB-R046 · No verified English nameCXSL2400208 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/04/01Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2400983 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2024/04/01Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2400981 Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2024/04/01Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2400980 Guangdong Jun Kang Pharma Co., Ltd. romanized; Tianjin Drug Research Institute Pharma Co., Ltd. romanized
2024/04/01New drug · Class 2.2 CB371口溶膜 · No verified English nameCXHL2400325 Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized
2024/03/30Import · Class 1 盐酸BAY 3283142片 · No verified English nameJXHL2400076 Bayer AG; Bayer Healthcare Company Ltd.
2024/03/30Import · Class 1 盐酸BAY 3283142片 · No verified English nameJXHL2400075 Bayer AG; Bayer Healthcare Company Ltd.
2024/03/30Generic · Class 3 Minoxidil LinimentCYHS2400977 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2024/03/30Generic · Class 3 Minoxidil LinimentCYHS2400976 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2024/03/30Generic · Class 3 Pentoxifylline InjectionCYHS2400975 Jiangxi Yuan Chao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/03/30Generic · Class 3 Nicorandil for InjectionCYHS2400972 Fujian Ze Rui Pharma Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2024/03/30Generic · Class 3 Nicorandil for InjectionCYHS2400971 Fujian Ze Rui Pharma Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized
2024/03/30New drug · Class 2.2 BCM875口溶膜 · No verified English nameCXHL2400324 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/03/30New drug · Class 2.2 BCM857口溶膜 · No verified English nameCXHL2400323 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/03/30New drug · Class 2.2 BCM857口溶膜 · No verified English nameCXHL2400322 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/03/30New drug · Class 2.2 ASKC200搽剂 · No verified English nameCXHL2400321 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized

70 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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