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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 419 drug applications between 19 June 2026 and 25 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 31 drug names.

2026/06/19 – 2026/06/25

Period
2026/06/19 to 2026/06/25, 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
419
Drugs with new generic filings (by drug name, de-duplicated)
31
Accepted this week, now under review
106

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

419filings, 43 of them generic

By application type

Application typeFilings
Supplement300
New drug47
Generic43
Import15
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
TCM190
Chemical drug153
Therapeutic biologic70
Biologic4
Prophylactic biologic2

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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection7438
2Fosfomycin Sodium For Injection3116
3Methylprednisolone Sodium Succinate for injection2112
4环硅酸锆钠散 · No verified English name2112
5Minoxidil Liniment2152
6马来酸左氨氯地平片 · No verified English name213
71.5 mmol/L钙碳酸氢钠血滤置换液 · No verified English name111
8Upadacitinib Sustained-release Tablets1143
9Acetylcysteine Tablets118
10Edaravone and Dexborneol Concentrated Solution for Injection1134

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

245 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized17160
2Dong E E Jiao Co., Ltd. romanized10100
3Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized770
4Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized730
5Novo Nordisk A/S720
6AstraZeneca AB650
7Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized550
8Shanxi Hua Kang Pharma Co., Ltd. romanized550
9Janssen-Cilag International NV530
10Shi Ze Bio Pharma (Shanghai) Co., Ltd. romanized520

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

81 this week

AcceptedDrugApplicants
2026/06/25Import · Class 3.1 莱达西贝普注射液 · No verified English nameJXSS2600054 LIB Therapeutics Inc.; PCI San Diego Inc.; Everest Medicines (China) Co. Ltd.
2026/06/25Import · Class 2.2 DS-1062a · No verified English nameJXSL2600150 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2026/06/25Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2600226 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/06/25Import · Class 2.4 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2600225 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/06/25Generic · Class 3 碳酸氢钠血滤置换液(钾2mmol/L无钙) · No verified English nameCYHS2601500 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2026/06/25Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601499 Chongqing Lai Mei Pharma Co., Ltd. romanized
2026/06/25Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2601497 Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized
2026/06/25Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601495 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanized
2026/06/25Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601494 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanized
2026/06/25Generic · Class 3 1.5 mmol/L钙碳酸氢钠血滤置换液 · No verified English nameCYHS2601492 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2026/06/25New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2600102 Qilu Pharmaceutical Co., Ltd.
2026/06/25New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSS2600101 Qilu Pharmaceutical Co., Ltd.
2026/06/25New drug · Class 1 EP-0210单抗注射液 · No verified English nameCXSL2600677 Chengdu You Luo Bio Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 注射用BL-M09D1 · No verified English nameCXSL2600676 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2026/06/25New drug · Class 1 注射用YL217 · No verified English nameCXSL2600675 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/06/25New drug · Class 1 BXP-001注射液 · No verified English nameCXSL2600674 Shenzhen Bei Wan Bio Technology Co., Ltd. romanized; Ge Yuan Zhi Shan (Shanghai) Bio Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 META 10-19注射液 · No verified English nameCXSL2600673 Shenzhen Lai Mang Bio Technology Co., Ltd. romanized; Hangzhou Lai Mang Bio Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 META 10-19注射液 · No verified English nameCXSL2600672 Shenzhen Lai Mang Bio Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 META 10-19注射液 · No verified English nameCXSL2600671 Shenzhen Lai Mang Bio Technology Co., Ltd. romanized
2026/06/25New drug · Class 2.2 TH5112 · No verified English nameCXHL2600761 Jilin Tian Heng Pharma Co., Ltd. romanized
2026/06/25New drug · Class 1 WD-890片 · No verified English nameCXHL2600760 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 DX1002片 · No verified English nameCXHL2600759 Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 注射用QHL-1231 · No verified English nameCXHL2600758 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 SA030注射液 · No verified English nameCXHL2600757 Suzhou Shi An Bio Technology Co., Ltd. romanized; Hangzhou Shi An Yuan Tai Bio Technology Co., Ltd. romanized; Shi An Yuan Tai (Shanghai) Bio Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 HRS-4139片 · No verified English nameCXHL2600756 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 HRS-4139片 · No verified English nameCXHL2600755 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/06/25New drug · Class 1 HRS-4139片 · No verified English nameCXHL2600754 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized
2026/06/24Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2601486 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2026/06/24Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2601485 Zhejiang Jian Feng Pharma Co., Ltd. romanized
2026/06/24Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2601484 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized

51 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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