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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 329 drug applications between 17 May 2024 and 23 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 62 drug names.

2024/05/17 – 2024/05/23

Period
2024/05/17 to 2024/05/23, 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
329
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
2

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

329filings, 83 of them generic

By application type

Application typeFilings
Supplement151
Generic83
New drug57
Import re-registration19
Import14
Unspecified5

By drug type

Drug typeFilings
Chemical drug223
TCM58
Therapeutic biologic43
Prophylactic biologic3
In vitro diagnostic reagent1
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Diprophylline Injection227
3Levofloxacin Eye Drops2216
4Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
5盐酸纳美芬注射液 · No verified English name221
6Glucosamine Sulfate Capsules2251
7Glyburide and Metformin Hydrochloride Tablets210
8利伐沙班干混悬剂 · No verified English name212
9Linagliptin and Metformin Hydrochloride Extended Release Tablets214
10Vonoprazan Fumarate Tablets2160

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

207 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shenzhen Xin Li Tai Pharma Co., Ltd. romanized820
2Sanofi Winthrop Industrie620
3Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized620
4Bracco Imaging S.P.A.610
5HUNAN WARRANT PHARMACEUTICAL CO.,LTD533
6Sichuan An Ke Kang Biopharmaceuticals Co., Ltd. romanized510
7Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
8Anhui Zhong Chen Pharmaceutical Co., Ltd. romanized440
9Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized430
10Boehringer Ingelheim Pharma GmbH & Co. KG420

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
2024/05/23Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2401551 Heilongjiang Ao Li Da Nai De Pharmaceutical Co., Ltd. romanized
2024/05/23Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2401549 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Zhong Fu Pharma Co., Ltd. romanized
2024/05/23Generic · Class 3 Indobufen TabletsCYHS2401547 Hebei Long Hai Pharma Co., Ltd. romanized
2024/05/23New drug · Class 1 Obexelimab注射液 · No verified English nameCXSL2400339 Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized
2024/05/23New drug · Class 1 DCTY1102注射液 · No verified English nameCXSL2400338 Beijing Ding Cheng Tai Yuan Bio Technology Co., Ltd. romanized
2024/05/23New drug · Class 1 SHR-7787注射液 · No verified English nameCXSL2400337 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/23New drug · Class 1 SHR-7787注射液 · No verified English nameCXSL2400336 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/23New drug · Class 1 复迈替尼片 · No verified English nameCXHS2400047 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2024/05/23New drug · Class 1 复迈替尼片 · No verified English nameCXHS2400046 Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2024/05/23New drug · Class 2.2; 2.4 HR19024注射液 · No verified English nameCXHL2400525 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/23New drug · Class 1 ENN0403胶囊 · No verified English nameCXHL2400524 Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized; Shanghai Yi Nuo Pharma Co., Ltd. romanized
2024/05/23New drug · Class 1 DG01片 · No verified English nameCXHL2400523 Suzhou De Gen Biopharmaceuticals Co., Ltd. romanized
2024/05/23New drug · Class 1 DG01片 · No verified English nameCXHL2400522 Suzhou De Gen Biopharmaceuticals Co., Ltd. romanized
2024/05/23New drug · Class 1 BG-68501片 · No verified English nameCXHL2400521 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/05/23New drug · Class 1 BG-68501片 · No verified English nameCXHL2400520 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/05/23New drug · Class 1 YZG-331片 · No verified English nameCXHL2400519 Zhongguo Yi Xue Ke College Drug Research Institute romanized
2024/05/22Import · Class 2.2 艾沙妥昔单抗注射液 · No verified English nameJXSS2400044 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH
2024/05/22Import · Class 2.2 艾沙妥昔单抗注射液 · No verified English nameJXSS2400043 Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH
2024/05/22Import · Class 1 Englumafusp alfa注射液 · No verified English nameJXSL2400098 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2024/05/22Import · Class 1 ABBV-382注射液 · No verified English nameJXSL2400097 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/05/22Import · Class 1 VSA001注射液 · No verified English nameJXHL2400116 Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd.
2024/05/22Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2401539 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/05/22Generic · Class 3 Famotidine InjectionCYHS2401538 Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/05/22Generic · Class 3 Famotidine InjectionCYHS2401537 Beijing Ge Lin Yi Rui Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2024/05/22Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2401536 Guangdong Nan Guo Pharma Co., Ltd. romanized
2024/05/22Generic · Class 3 Cimetidine InjectionCYHS2401535 Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/05/22Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2401534 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/05/22Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2401533 HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/05/22Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2401529 Anhui Pioneer Pharmaceutical Co., Ltd
2024/05/22Generic · Class 3 Diprophylline InjectionCYHS2401528 Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized

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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