YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 161 drug applications between 14 February 2024 and 20 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 32 drug names.

2024/02/14 – 2024/02/20

Period
2024/02/14 to 2024/02/20, 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
161
Drugs with new generic filings (by drug name, de-duplicated)
32
Accepted this week, now under review
6

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

161filings, 42 of them generic

By application type

Application typeFilings
Supplement84
Generic42
New drug26
Import7
Unspecified1
Import re-registration1

By drug type

Drug typeFilings
Chemical drug106
TCM34
Therapeutic biologic20
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

32 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
2Topiroxostat Tablets310
3Latamoxef Sodium for Injection311
4Piperacillin Sodium for Injection2116
5Azilsartan Medoxomil Potassium Tablets2135
6Esomeprazole Magnesium for Delayed-release Oral Suspension214
7Fluvoxamine Maleate Tablets210
8Sodium Valproate Oral Solution111
9Perampanel oral suspension112
10复方氨基酸注射液(17AA-Ⅲ) · No verified English name112

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

98 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang Yu Ze Tang Pharmaceutical Co., Ltd. romanized10100
2CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.1030
3Qi Lu An Ti Pharmaceutical Co., Ltd. romanized623
4Sichuan Yi Ke Cao Pharma Co., Ltd. romanized550
5Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized410
6Haerbin Kang Ze Yuan Pharma Co., Ltd. romanized330
7Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized323
8Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized323
9Zhong Fu Pharma Co., Ltd. romanized310
10Le Pu Pharma Co., Ltd. romanized313

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

56 this week

AcceptedDrugApplicants
2024/02/20Import · Class 2.4 布地奈德硫酸沙丁胺醇吸入气雾剂 · No verified English nameJXHL2400036 AstraZeneca Pharmaceuticals LP; AstraZeneca Global R&D (China) Co. Ltd.
2024/02/20Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2400642 Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized
2024/02/20Generic · Class 3 Isoniazid InjectionCYHS2400641 Hebei Long Hai Pharma Co., Ltd. romanized; Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/02/20Generic · Class 3 Latamoxef Sodium for InjectionCYHS2400637 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Latamoxef Sodium for InjectionCYHS2400636 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Latamoxef Sodium for InjectionCYHS2400635 Qi Lu An Ti Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2400633 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2400632 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2400627 Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2400625 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2400624 Le Pu Pharma Co., Ltd. romanized
2024/02/20Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2400623 Le Pu Pharma Co., Ltd. romanized
2024/02/20Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2400622 Le Pu Pharma Co., Ltd. romanized
2024/02/20Generic · Class 3 Topiroxostat TabletsCYHL2400043 Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Topiroxostat TabletsCYHL2400042 Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Topiroxostat TabletsCYHL2400041 Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized
2024/02/20Generic · Class 3 Brivaracetam Solution for InjectionCYHL2400040 Jiangxi Yin Tao Pharma Co., Ltd. romanized
2024/02/20New drug · Class 1 注射用ZB001 · No verified English nameCXSL2400133 Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized
2024/02/20New drug · Class 1 TVAX-008注射液 · No verified English nameCXSL2400132 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2024/02/20New drug · Class 2.5 带状疱疹减毒活疫苗 · No verified English nameCXSL2400131 Chengdu Bai Ao Te Ke Bio Technology Co., Ltd. romanized
2024/02/20New drug · Class 1 注射用KKD001 · No verified English nameCXSL2400130 Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized
2024/02/20New drug · Class 1 SHR-2173注射液 · No verified English nameCXSL2400129 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/02/20New drug · Class 1 注射用SHR-A1921 · No verified English nameCXSL2400128 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/02/20New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2400127 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/02/20New drug · Class 1 注射用SHR-9839 · No verified English nameCXSL2400126 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/02/20New drug · Class 1 EMB-06注射液 · No verified English nameCXSL2400125 Shanghai An Mai Bio Technology Co., Ltd. romanized
2024/02/20New drug · Class 1 ADRX-0706 · No verified English nameCXSL2400124 Shanghai De Feng Pharma Co., Ltd. romanized
2024/02/20New drug · Class 2.2 盐酸氨溴索口服冻干片 · No verified English nameCXHS2400014 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Shaanxi Liang Zi Gao Ke Pharma Co., Ltd. romanized
2024/02/20New drug · Class 2.2 盐酸氨溴索口服冻干片 · No verified English nameCXHS2400013 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.; Shaanxi Liang Zi Gao Ke Pharma Co., Ltd. romanized
2024/02/20New drug · Class 1 INR101注射液 · No verified English nameCXHL2400200 Yun He Pharmaceuticals (Tianjin) Co., Ltd. romanized

26 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.