YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 87 drug applications between 20 January 2023 and 26 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 22, covering 15 drug names.

2023/01/20 – 2023/01/26

Period
2023/01/20 to 2023/01/26, 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
87
Drugs with new generic filings (by drug name, de-duplicated)
15
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

87filings, 22 of them generic

By application type

Application typeFilings
Supplement44
Generic22
New drug15
Unspecified3
Import3

By drug type

Drug typeFilings
Chemical drug75
Therapeutic biologic7
TCM5

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

15 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Quetiapine Fumarate Tablets310
3Lacosamide Injection210
4Sodium Hyaluronate Eye Drops2130
5Doxorubicin Hydrochloride Liposome Injection212
6Betamethasone Sodium Phosphate Injection115
7地氯雷他定口服溶液 · No verified English name1126
8Fusidic Acid Cream1115
9Levosimendan Injection111
10Pentoxifylline Injection113

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

55 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1MUNDIPHARMA GmbH610
2Pfizer Inc.520
3Ping Guang Pharmaceutical Co., Ltd. romanized441
4Janssen Research & Development LLC330
5Pfizer Australia Pty Ltd310
6Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized310
7Guangdong Dong Yang Guang Pharma Co., Ltd. romanized310
8Jiangxi Shimei Pharmaceutical Co., Ltd313
9ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.313
10Bausch & Lomb Incorporated210

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

20 this week

AcceptedDrugApplicants
2023/01/21New drug · Class 1 CT041自体CAR T细胞注射液 · No verified English nameCXSL2300059 Shanghai Ke Ji Pharmaceutical Co., Ltd. romanized
2023/01/20Import · Class 1 VSA003注射液 · No verified English nameJXHL2300013 Visirna Therapeutics HK Limited; Visirna Therapeutics (Shanghai) Co Ltd.
2023/01/20Import · Class 1 Milvexian片 · No verified English nameJXHL2300012 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/01/20Generic · Class 3 Pentoxifylline InjectionCYHS2300207 Ping Guang Pharmaceutical Co., Ltd. romanized
2023/01/20Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2300203 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2023/01/20Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2300199 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 2.2; 2.3 HYR0201颗粒 · No verified English nameCXZL2300003 Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 1 注射用SHR-4602 · No verified English nameCXSL2300058 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/01/20New drug · Class 1 注射用AP026 · No verified English nameCXSL2300057 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/01/20New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2300016 Bei Da Pharma Co., Ltd. romanized
2023/01/20New drug · Class 1 甲磺酸贝福替尼胶囊 · No verified English nameCXHS2300015 Bei Da Pharma Co., Ltd. romanized
2023/01/20New drug · Class 2.4 甲磺酸伏美替尼片 · No verified English nameCXHL2300110 Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized
2023/01/20New drug · Class 1 QHRD107胶囊 · No verified English nameCXHL2300109 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 1 QHRD107胶囊 · No verified English nameCXHL2300108 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 1 QHRD107胶囊 · No verified English nameCXHL2300107 Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300103 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300102 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/01/20New drug · Class 2.2 苯磺酸氨氯地平颗粒 · No verified English nameCXHL2300101 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/01/20New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2300100 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2023/01/20New drug · Class 1 G201-Na胶囊 · No verified English nameCXHL2300099 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized

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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