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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 318 drug applications between 28 March 2024 and 3 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 58 drug names.

2024/03/28 – 2024/04/03

Period
2024/03/28 to 2024/04/03, 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
318
Drugs with new generic filings (by drug name, de-duplicated)
58
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

318filings, 80 of them generic

By application type

Application typeFilings
Supplement152
Generic80
New drug47
Import23
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug216
TCM51
Therapeutic biologic48
Biologic3

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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection4313
2Minoxidil Liniment4352
3Diprophylline Injection227
4Acetylcysteine Solution For Inhalation224
5Bromhexine Hydrochloride Injection228
6Tacrolimus Capsules212
7Selexipag Tablets2124
8Multiple Electrolytes and Sodium Acetate Injection214
9Olmesartan Medoxomil Orally Disintegrating Tablets210
10Ibuprofen Injection218

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

194 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tong Hua Zheng Yuan Pharma Co., Ltd. romanized970
2Pfizer Inc.740
3Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized521
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
5Myokardia Inc.510
6Haerbin Han Bang Medical Technology Co., Ltd. romanized510
7Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.443
9Jiangsu Vanguard Pharmaceutical Co., Ltd.434
10Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410

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

108 this week

AcceptedDrugApplicants
2024/04/03Import · Class 1 CID-103注射液 · No verified English nameJXSL2400067 CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd.
2024/04/03Generic · Class 3 Methocarbamol InjectionCYHS2401003 Zhejiang AngLiKang Pharmaceutical CO.,LTD.; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2024/04/03Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2400998 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2024/04/03Generic · Class 3 Ferrous Succinate TabletsCYHS2400997 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2024/04/03Generic · Class 3 Fudosteine oral solutionCYHS2400996 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/04/03Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2400995 Beijing Foyou Pharma CO.,LTD
2024/04/03Generic · Class 3 立他司特滴眼液 · No verified English nameCYHL2400069 Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized
2024/04/03Generic · Class 3 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400068 Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized
2024/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2400037 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2024/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2400036 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2024/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2400035 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2024/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2400034 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2024/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2400033 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2024/04/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2400032 Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized
2024/04/03New drug · Class 1 HY1272注射液 · No verified English nameCXSL2400211 Heng Yi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2024/04/03New drug · Class 3.4 注射用重组人凝血因子Ⅷ · No verified English nameCXSL2400210 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/04/03New drug · Class 1 SYS6020注射液 · No verified English nameCXSL2400209 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/04/03New drug · Class 1 CS060304片 · No verified English nameCXHL2400334 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/04/03New drug · Class 1 CS060304片 · No verified English nameCXHL2400333 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/04/03New drug · Class 1 CS060304片 · No verified English nameCXHL2400332 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/04/03New drug · Class 1 CS060304片 · No verified English nameCXHL2400331 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/04/03New drug · Class 1 HY-021068片 · No verified English nameCXHL2400330 Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized; Hefei En Rui Te Pharma Co., Ltd. romanized
2024/04/03New drug · Class 1 HRS-7249注射液 · No verified English nameCXHL2400329 Shanghai Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized; Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/04/03New drug · Class 1 GFH375片 · No verified English nameCXHL2400328 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/04/03New drug · Class 1 GFH375片 · No verified English nameCXHL2400327 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/04/03New drug · Class 1 BC-007 · No verified English nameCXHL2400326 Mo Hua (Wuxi) Bio Technology Co., Ltd. romanized
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.

78 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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