YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 142 drug applications between 29 April 2023 and 5 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 19 drug names.

2023/04/29 – 2023/05/05

Period
2023/04/29 to 2023/05/05, 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
142
Drugs with new generic filings (by drug name, de-duplicated)
19
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

142filings, 21 of them generic

By application type

Application typeFilings
Supplement84
New drug23
Generic21
Import8
Import re-registration6

By drug type

Drug typeFilings
Chemical drug93
TCM26
Therapeutic biologic22
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

19 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ipratropium Bromide Inhalation Solution212
2Amikacin Sulfate injection214
3Tadalafil Tablets1123
4Indobufen Tablets116
5吸入用布地奈德混悬液 · No verified English name117
6头孢丙烯干混悬剂 · No verified English name112
7Levetiracetam Oral Solution113
8Pentoxifylline Injection113
9Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution1123
10Roxatidine Acetate Hydrochloride For Injection115

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

78 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized20100
2Sichuan He Li Xin Jian Pharma Co., Ltd. romanized440
3Shaanxi Qing Hua Zi Guang Bio Technology Co., Ltd. romanized440
4Janssen-Cilag AG410
5McNeil Sweden AB410
6Merck Sharp & Dohme LLC410
7Ha Yao Group Pharmaceutical Factory romanized410
8Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized330
9Heilongjiang Jia Yue Ze Medical Technology Co., Ltd. romanized330
10Suzhou Hong Sen Pharma Co., Ltd. romanized323

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

40 this week

AcceptedDrugApplicants
2023/05/05Generic · Class 3 Indobufen TabletsCYHS2301213 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/05/05Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2301212 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/05/05Generic · Class 3 Amikacin Sulfate injectionCYHS2301211 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/05/05Generic · Class 3 Amikacin Sulfate injectionCYHS2301210 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/05/05Generic · Class 3 Azilsartan and Amlodipine TabletsCYHL2300069 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/05/05New drug · Class 1 注射用IBD0333 · No verified English nameCXSL2300306 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2023/05/05New drug · Class 1 QL1706注射液 · No verified English nameCXSL2300305 Qilu Pharmaceutical Co., Ltd.
2023/05/05New drug · Class 1 LM103注射液 · No verified English nameCXSL2300304 Suzhou Lan Ma Medical Technology Co., Ltd. romanized
2023/05/05New drug · Class 1 IBI354 · No verified English nameCXSL2300303 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/05/05New drug · Class 1 TST001注射液 · No verified English nameCXSL2300302 Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized
2023/05/05New drug · Class 1 HS329片 · No verified English nameCXHL2300459 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2023/05/05New drug · Class 1 HS329片 · No verified English nameCXHL2300458 Zhejiang Hai Zheng Pharma Co., Ltd. romanized
2023/05/05New drug · Class 1 JMKX000197注射液 · No verified English nameCXHL2300457 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/05/05New drug · Class 1 JMKX000197注射液 · No verified English nameCXHL2300456 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/05/04Generic · Class 3 维生素D口服溶液 · No verified English nameCYHS2301206 Guangzhou Lang Sheng Pharma Co., Ltd. romanized
2023/05/04New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2300301 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2023/05/04New drug · Class 3.3 德谷门冬双胰岛素注射液 · No verified English nameCXSL2300300 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2023/05/04New drug · Class 1 ISM3091胶囊 · No verified English nameCXHL2300455 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/05/04New drug · Class 1 ISM3091胶囊 · No verified English nameCXHL2300454 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300085 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300084 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300083 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 MK-6024注射液 · No verified English nameJXSL2300082 Merck Sharp & Dohme LLC; MSD R&D(China)Co. Ltd.
2023/04/29Import · Class 1 BBP-398胶囊 · No verified English nameJXHL2300102 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/04/29Import · Class 1 BBP-398胶囊 · No verified English nameJXHL2300101 LianBio Development (HK) Limited; Shanghai LianBio Development Co. Ltd.
2023/04/29Import · Class 1 AMG 890 · No verified English nameJXHL2300100 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2023/04/29Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301203 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2023/04/29Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2301198 Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized
2023/04/29Generic · Class 3 Pentoxifylline InjectionCYHS2301197 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/04/29Generic · Class 3 Mepivacaine Hydrochloride InjectionCYHS2301195 Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized; CISEN PHARMACEUTICAL CO., LTD.

10 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.