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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 499 drug applications between 21 June 2026 and 27 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 44 drug names.

2026/06/21 – 2026/06/27

Period
2026/06/21 to 2026/06/27, 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
499
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
135

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

499filings, 60 of them generic

By application type

Application typeFilings
Supplement348
Generic60
New drug60
Import17
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
TCM218
Chemical drug196
Therapeutic biologic79
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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Nafamostat Mesilate for Injection9538
2Fosfomycin Sodium For Injection3116
3Methylprednisolone Sodium Succinate for injection2112
4环硅酸锆钠散 · No verified English name2112
5Bromhexine Hydrochloride Oral Solution2122
6Terbutaline Sulfate Injection212
7Minoxidil Liniment2152
8马来酸左氨氯地平片 · No verified English name213
91.5 mmol/L钙碳酸氢钠血滤置换液 · No verified English name111
10Upadacitinib Sustained-release Tablets1143

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

290 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
4AstraZeneca AB760
5Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized730
6Novo Nordisk A/S720
7Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized550
8Shanxi Hua Kang Pharma Co., Ltd. romanized550
9Janssen-Cilag International NV530
10Shanghai Shang Yao Xin Ya Pharma 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

105 this week

AcceptedDrugApplicants
2026/06/26Import · Class 1 托雷奇单抗注射液 · No verified English nameJXSS2600055 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/06/26Generic · Class 3 聚普瑞锌口崩片 · No verified English nameCYHS2601515 Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2026/06/26Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2601514 Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized
2026/06/26Generic · Class 3 Terbutaline Sulfate InjectionCYHS2601511 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/06/26Generic · Class 3 Terbutaline Sulfate InjectionCYHS2601509 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/06/26Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601508 Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized
2026/06/26Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2601507 Guangdong Nan Guo Pharma Co., Ltd. romanized
2026/06/26Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2601506 Guangdong Nan Guo Pharma Co., Ltd. romanized
2026/06/26Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601505 Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized
2026/06/26Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601504 Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized
2026/06/26Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2601502 Hefei He Yuan Pharma Co., Ltd. romanized
2026/06/26New drug · Class 2.2 小儿化积颗粒 · No verified English nameCXZS2600034 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2026/06/26New drug · Class 3.1 泻白散颗粒 · No verified English nameCXZS2600033 Guangzhou Wang Lao Ji Pharma Co., Ltd. romanized
2026/06/26New drug · Class 1.1 薷蒿达湿颗粒 · No verified English nameCXZL2600056 Hangzhou Hong Yu Pharmaceuticals Technology Co., Ltd. romanized
2026/06/26New drug · Class 1 ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2600679 Beijing Shun Xin Xiang Yu Bio Technology Co., Ltd. romanized
2026/06/26New drug · Class 1 EP-0210单抗注射液 · No verified English nameCXSL2600678 Chengdu You Luo Bio Technology Co., Ltd. romanized
2026/06/26New drug · Class 1 维卡格雷胶囊 · No verified English nameCXHS2600091 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
2026/06/26New drug · Class 1 EIK1005片 · No verified English nameCXHL2600768 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/26New drug · Class 1 EIK1005片 · No verified English nameCXHL2600767 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/26New drug · Class 1 EIK1005片 · No verified English nameCXHL2600766 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/26New drug · Class 1 IG001119片 · No verified English nameCXHL2600765 Yang Guang An Jin (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/06/26New drug · Class 1 IG001119片 · No verified English nameCXHL2600764 Yang Guang An Jin (Nanjing) Biopharmaceuticals Technology Co., Ltd. romanized
2026/06/26New drug · Class 1 CS0159片 · No verified English nameCXHL2600763 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2026/06/26New drug · Class 2.2 SYH9087注射液 · No verified English nameCXHL2600762 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD.
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

75 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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