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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 209 drug applications between 30 March 2024 and 5 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 37 drug names.

2024/03/30 – 2024/04/05

Period
2024/03/30 to 2024/04/05, 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
209
Drugs with new generic filings (by drug name, de-duplicated)
37
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

209filings, 46 of them generic

By application type

Application typeFilings
Supplement101
Generic46
New drug35
Import17
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug139
TCM37
Therapeutic biologic31
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

37 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Bumetanide Injection2213
2Tacrolimus Capsules212
3Deferasirox Tablets213
4Olmesartan Medoxomil Orally Disintegrating Tablets210
5Nicorandil for Injection211
6Vardenafil Hydrochloride Tablets214
7Minoxidil Liniment2152
8Atosiban Acetate Injection212
9Febuxostat Tablets2112
10二甲双胍恩格列净片(Ⅰ) · No verified English name117

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

135 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tong Hua Zheng Yuan Pharma Co., Ltd. romanized530
2Hangzhou Jiu Yuan Ji Yin Biopharmaceuticals Co., Ltd. romanized521
3Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized440
4Jiangsu Vanguard Pharmaceutical Co., Ltd.434
5Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.410
6Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized410
7Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized410
8Shandong Er Ye Pharmaceutical Co., Ltd. romanized410
9ViiV Healthcare BV330
10Shandong Hao Fu Pharma Group Pharmaceutical Co., Ltd. romanized330

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

72 this week

AcceptedDrugApplicants
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
2024/04/04New drug · Class 1 PH009-1片 · No verified English nameCXHL2400336 Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized
2024/04/04New drug · Class 1 PH009-1片 · No verified English nameCXHL2400335 Suzhou Pu He Pharmaceuticals Technology Co., Ltd. romanized
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

42 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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