YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 417 drug applications between 15 August 2023 and 21 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 106, covering 75 drug names.

2023/08/15 – 2023/08/21

Period
2023/08/15 to 2023/08/21, 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
417
Drugs with new generic filings (by drug name, de-duplicated)
75
Accepted this week, now under review
1

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

417filings, 106 of them generic

By application type

Application typeFilings
Supplement213
Generic106
New drug57
Import32
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug301
TCM63
Therapeutic biologic46
Prophylactic biologic6
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

75 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gadoteridol Injection413
2Lactulose Oral Solution3234
3Empagliflozin Tablets3218
4Urapidil Hydrochloride Injection326
5Iopromide Injection3227
6恩那度司他片 · No verified English name310
7Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral Solution222
8Labetalol Hydrochloride Injection224
9Mupirocin Ointment2230
10Avatrombopag Maleate Tablets220

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

248 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized24191
2Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized990
3Changsha Ai Bei Gao Pharma Co., Ltd. romanized550
4Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized540
5Guangdong Da Zhong Pharmaceutical Co., Ltd. romanized530
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.531
7Myokardia Inc.510
8Janssen Research & Development LLC420
9Zhejiang AngLiKang Pharmaceutical CO.,LTD.422
10Eli Lilly and Company410

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

124 this week

AcceptedDrugApplicants
2023/08/21Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2300082 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/08/21Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2300081 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/08/21Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2300080 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/08/21Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHS2300079 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/08/21Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2302203 Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized
2023/08/21Generic · Class 3 Potassium Chloride InjectionCYHS2302201 Hainan Jing Ze Kang Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/08/21Generic · Class 3 立他司特滴眼液 · No verified English nameCYHL2300103 Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized
2023/08/21New drug · Class 1 ABSK051注射液 · No verified English nameCXHL2300898 Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized
2023/08/19Import · Class 3.1 特立妥单抗注射液 · No verified English nameJXSS2300070 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2023/08/19Import · Class 3.1 特立妥单抗注射液 · No verified English nameJXSS2300069 Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd.
2023/08/19Import · Class 2.2 Faricimab注射液 · No verified English nameJXSL2300157 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/08/19Generic · Class 3 Hydrotalcite SuspensionCYHS2302200 Guangxi Bai Hui Pharmaceuticals Technology Co., Ltd. romanized; Guangxi Nanning Bai Hui Pharma Group Co., Ltd. romanized
2023/08/19Generic · Class 3 Digoxin InjectionCYHS2302199 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/08/19Generic · Class 3 头孢丙烯干混悬剂 · No verified English nameCYHS2302198 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2023/08/19Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2302197 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/08/19Generic · Class 3 Bumetanide InjectionCYHS2302195 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/08/19Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2302193 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized
2023/08/19New drug · Class 2.3 连榆烧伤膏 · No verified English nameCXZL2300052 Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized
2023/08/19New drug · Class 2.2 SPH(ZX)003 · No verified English nameCXHL2300897 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2023/08/19New drug · Class 2.2 SPH(ZX)003 · No verified English nameCXHL2300896 Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized
2023/08/19New drug · Class 1 WXWH0240片 · No verified English nameCXHL2300895 CISEN PHARMACEUTICAL CO., LTD.
2023/08/19New drug · Class 1 WXWH0240片 · No verified English nameCXHL2300894 CISEN PHARMACEUTICAL CO., LTD.
2023/08/19New drug · Class 1 HS-10374片 · No verified English nameCXHL2300893 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/08/19New drug · Class 1 HS-10374片 · No verified English nameCXHL2300892 Changzhou Heng Bang Pharma Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/08/19New drug · Class 2.2 伏立康唑滴眼液 · No verified English nameCXHL2300891 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/08/18Import · Class 2.2 Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300156 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300155 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300154 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300153 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/18Import · Class 1 BION-1301注射液 · No verified English nameJXSL2300152 Chinook Therapeutics Inc.; SanReno Therapeutics (Shanghai) Limited

94 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.