YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 394 drug applications between 12 July 2023 and 18 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 52 drug names.

2023/07/12 – 2023/07/18

Period
2023/07/12 to 2023/07/18, 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
394
Drugs with new generic filings (by drug name, de-duplicated)
52
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

394filings, 74 of them generic

By application type

Application typeFilings
Supplement196
Generic74
New drug60
Import34
Import re-registration22
Unspecified8

By drug type

Drug typeFilings
Chemical drug289
Therapeutic biologic50
TCM47
Prophylactic biologic7
In vitro diagnostic reagent1

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

52 drugs with new generic filings; top 10 listed

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized32230
2AstraZeneca AB1340
3Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized880
4Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized660
5Boehringer Ingelheim International GmbH640
6Upjohn Manufacturing Ireland Unlimited Company610
7Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized610
8Intas Pharmaceuticals. Ltd.510
9Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized440
10Roche Pharma (Schweiz) AG420

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

111 this week

AcceptedDrugApplicants
2023/07/18Import · Class 1 HFB200301注射液 · No verified English nameJXSL2300130 HiFiBiO Inc.; HiFiBiO (Hangzhou) Co. Ltd
2023/07/18Import · Class 1 AZD9833片 · No verified English nameJXHL2300170 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2023/07/18Import · Class 1 瑞普替尼胶囊 · No verified English nameJXHL2300169 Bristol-Myers Squibb Company
2023/07/18Import · Class 1 瑞普替尼胶囊 · No verified English nameJXHL2300168 Bristol-Myers Squibb Company
2023/07/18Import · Class 1 INCB099280片 · No verified English nameJXHL2300167 Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd.
2023/07/18Generic · Class 3 Lidocaine Hydrochloride Topical SolutionCYHS2301936 Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Scopolamine Butylbromide InjectionCYHS2301935 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2301932 Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; Jiangsu Vanguard Pharmaceutical Co., Ltd.
2023/07/18Generic · Class 3 Diprophylline InjectionCYHS2301931 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/07/18Generic · Class 3 Indobufen TabletsCYHS2301929 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Indobufen TabletsCYHS2301928 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2023/07/18Generic · Class 3 Multiple Vitamins InjectionCYHS2301923 Shandong Lu Sheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2023/07/18Generic · Class 3 Sodium sulfate, magnesium sulfate, and potassium chloride TabletsCYHL2300088 Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized
2023/07/18New drug · Class 3.1 一贯煎颗粒 · No verified English nameCXZS2300014 Shen Wei Pharma Group Co., Ltd. romanized
2023/07/18New drug · Class 1 AK0610注射液 · No verified English nameCXSL2300492 Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/18New drug · Class 1 KL-A167注射液 · No verified English nameCXSL2300491 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/07/18New drug · Class 1 注射用SKB264 · No verified English nameCXSL2300490 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2023/07/18New drug · Class 1 K1注射液 · No verified English nameCXSL2300488 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2023/07/18New drug · Class 1 K1注射液 · No verified English nameCXSL2300487 Jiangsu Kang He Biopharmaceutical Co., Ltd. romanized
2023/07/18New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2300486 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/07/18New drug · Class 1 LX-132胶囊 · No verified English nameCXHL2300794 Guangzhou Li Xin Bio Technology Co., Ltd. romanized
2023/07/18New drug · Class 1 LX-132胶囊 · No verified English nameCXHL2300793 Guangzhou Li Xin Bio Technology Co., Ltd. romanized
2023/07/18New drug · Class 1 SC0011片 · No verified English nameCXHL2300792 Wuxi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2023/07/18New drug · Class 1 GT1708F片 · No verified English nameCXHL2300791 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2023/07/18New drug · Class 1 GT1708F片 · No verified English nameCXHL2300790 Suzhou Kai Tuo Pharma Co., Ltd. romanized
2023/07/17Import · Class 1 AZD9833片 · No verified English nameJXHL2300166 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2023/07/17Import · Class 1 AZD5305 · No verified English nameJXHL2300165 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/07/17Import · Class 1 AZD5305 · No verified English nameJXHL2300164 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/07/17Import · Class 1 AZD5305 · No verified English nameJXHL2300163 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2023/07/17Import · Class 1 AZD5305 · No verified English nameJXHL2300162 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.

81 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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