YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 423 drug applications between 10 May 2023 and 16 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 50 drug names.

2023/05/10 – 2023/05/16

Period
2023/05/10 to 2023/05/16, 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
423
Drugs with new generic filings (by drug name, de-duplicated)
50
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

423filings, 69 of them generic

By application type

Application typeFilings
Supplement252
Generic69
New drug55
Import24
Import re-registration13
Unspecified10

By drug type

Drug typeFilings
Chemical drug254
TCM123
Therapeutic biologic46

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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1硝普钠氯化钠注射液 · No verified English name413
2Famotidine Injection338
3吸入用七氟烷 · No verified English name310
4Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets310
5Levofloxacin Oral Solution221
6Levofloxacin Eye Drops2216
7Carbazochrome Sodium Sulfonate Injection211
8Ipratropium Bromide Inhalation Solution212
9Vonoprazan Fumarate Tablets2160
10Quetiapine Fumarate Extended-release Tablets210

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

204 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized62500
2Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized15150
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized15140
4Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized14100
5Bard Pharmaceuticals Limited730
6AbbVie Inc.620
7Eli Lilly and Company610
8Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
9Bright Future Pharmaceuticals Factory540
10Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized520

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

99 this week

AcceptedDrugApplicants
2023/05/16Import · Class 2.2 Glofitamab注射液 · No verified English nameJXSL2300093 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/05/16Import · Class 1 CC-99282胶囊 · No verified English nameJXHL2300117 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd
2023/05/16Import · Class 2.4 Infigratinib胶囊 · No verified English nameJXHL2300116 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/05/16Import · Class 2.4 Infigratinib胶囊 · No verified English nameJXHL2300115 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/05/16Generic · Class 3 Levofloxacin Oral SolutionCYHS2301322 Hubei Xin Ze Fei Pharma Co., Ltd. romanized
2023/05/16Generic · Class 3 Famotidine InjectionCYHS2301317 Sichuan Pharmaceutical Formulations Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2023/05/16Generic · Class 3 注射用水溶性维生素 · No verified English nameCYHS2301315 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/05/16New drug · Class 1.1 枳术通便颗粒 · No verified English nameCXZL2300035 Jian Min Pharma Group Co., Ltd. romanized
2023/05/16New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSL2300342 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized
2023/05/16New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSL2300341 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized
2023/05/16New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSL2300340 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized
2023/05/16New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSL2300339 Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized
2023/05/16New drug · Class 1 注射用LBL-034 · No verified English nameCXSL2300338 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2023/05/16New drug · Class 1 AZD5863 · No verified English nameCXSL2300337 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2023/05/16New drug · Class 1 甲磺酸帕拉德福韦片 · No verified English nameCXHS2300049 Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized
2023/05/16New drug · Class 1 TQB3912片 · No verified English nameCXHL2300527 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/05/16New drug · Class 1 TQB3912片 · No verified English nameCXHL2300526 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/05/16New drug · Class 2.3 TAF-001乳膏 · No verified English nameCXHL2300525 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2023/05/16New drug · Class 1 SPH7050颗粒 · No verified English nameCXHL2300524 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/05/16New drug · Class 1 SPH7050颗粒 · No verified English nameCXHL2300523 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/05/16New drug · Class 1 YY201片 · No verified English nameCXHL2300522 Shanghai Yu Yao Bio Technology Co., Ltd. romanized
2023/05/16New drug · Class 1 YY201片 · No verified English nameCXHL2300521 Shanghai Yu Yao Bio Technology Co., Ltd. romanized
2023/05/16New drug · Class 1 MH004乳膏 · No verified English nameCXHL2300520 Ming Hui Pharmaceuticals (Hangzhou) Co., Ltd. romanized
2023/05/16New drug · Class 1 GT929胶囊 · No verified English nameCXHL2300519 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/05/16New drug · Class 1 GT929胶囊 · No verified English nameCXHL2300518 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/05/16New drug · Class 1 GT929胶囊 · No verified English nameCXHL2300517 Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/05/15Generic · Class 3 Phosribbon combination granulesCYHS2301310 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Tian Ji Cao Tang Pharmaceutical Co., Ltd. romanized
2023/05/13Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2301309 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/05/13Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301308 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/05/13Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2301307 Henan Run Hong Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized

69 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.