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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 446 drug applications between 14 July 2026 and 20 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 49 drug names.

2026/07/14 – 2026/07/20

Period
2026/07/14 to 2026/07/20, 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
446
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
152

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

446filings, 70 of them generic

By application type

Application typeFilings
Supplement280
Generic70
New drug58
Import20
Unspecified12
Import re-registration6

By drug type

Drug typeFilings
Chemical drug221
TCM145
Therapeutic biologic69
Prophylactic biologic8
Biologic3

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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Baricitinib Tablets4232
2Dotinurad Tablets3155
3Brivaracetam Tablets3119
4瑞维那新吸入溶液 · No verified English name2253
5Buprenorphine Transdermal Patches216
6Ethyl Iosapentate Capsules2127
7Gatifloxacin Eye Drops213
8Oxaliplatin Injection214
9Bisoprolol Fumarate Tablets216
10Cefuroxime Sodium for Injection218

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

270 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Ji Er Ji Pharma Co., Ltd. romanized990
2Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized990
3An Kang Zheng Da Pharmaceutical Co., Ltd. romanized650
4Pfizer Inc.620
5Fresenius Kabi Austria GmbH610
6Shanxi Huang He Zhong Yao Co., Ltd. romanized550
7Novo Nordisk A/S520
8Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized520
9Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized510
10Shenzhen Shi Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized510

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
2026/07/20Import · Class 3.1 伊匹木单抗注射液 · No verified English nameJXSS2600063 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Samsung Biologics Co. Ltd; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/07/20Import · Class 1 AZD5335 · No verified English nameJXSL2600172 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/07/20Import · Class 2.4 贝组替凡片 · No verified English nameJXHL2600279 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/07/20Import · Class 2.4 塞伐艾替尼片 · No verified English nameJXHL2600278 Bayer AG; Bayer Healthcare Company Ltd.
2026/07/20Import · Class 2.4 塞伐艾替尼片 · No verified English nameJXHL2600277 Bayer AG; Bayer Healthcare Company Ltd.
2026/07/20Generic · Class 3 Esketamine Hydrochloride InjectionCYHS2601737 Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized
2026/07/20Generic · Class 3 布美他尼片 · No verified English nameCYHS2601736 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/07/20Generic · Class 3 Potassium Chloride InjectionCYHS2601732 Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Xian Li Jun Kang Le Pharmaceutical Co., Ltd. romanized
2026/07/20Generic · Class 3 盐酸奥洛他定口崩片 · No verified English nameCYHS2601723 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2026/07/20Generic · Class 3 Dipyridamole TabletsCYHS2601722 Chengdu Gui He Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/07/20New drug · Class 1 注射用CS5007 · No verified English nameCXSL2600752 Ji Shi Pharma (Suzhou) Co., Ltd. romanized
2026/07/20New drug · Class 1 EB070注射液 · No verified English nameCXSL2600751 Bai Tai Bio Pharma Co., Ltd. romanized
2026/07/20New drug · Class 1 EB070注射液 · No verified English nameCXSL2600750 Bai Tai Bio Pharma Co., Ltd. romanized
2026/07/20New drug · Class 1 EB070注射液 · No verified English nameCXSL2600749 Bai Tai Bio Pharma Co., Ltd. romanized
2026/07/20New drug · Class 1.2 冻干重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2600748 Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized; Xiamen University romanized
2026/07/20New drug · Class 1 SHR-3201注射液 · No verified English nameCXSL2600746 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/07/20New drug · Class 1 VCT220片 · No verified English nameCXHS2600104 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2026/07/20New drug · Class 1 VCT220片 · No verified English nameCXHS2600103 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2026/07/20New drug · Class 2.2 N02 · No verified English nameCXHL2600879 Beijing Bo En Te Pharma Co., Ltd. romanized
2026/07/20New drug · Class 2.2 N02 · No verified English nameCXHL2600878 Beijing Bo En Te Pharma Co., Ltd. romanized
2026/07/20New drug · Class 1 VCT220片 · No verified English nameCXHL2600877 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/07/20New drug · Class 1 VCT220片 · No verified English nameCXHL2600876 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/07/20New drug · Class 1 VCT220片 · No verified English nameCXHL2600875 Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized
2026/07/20New drug · Class 2.4 HS-10561胶囊 · No verified English nameCXHL2600874 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/20New drug · Class 1 BAY 3713372 片 · No verified English nameCXHL2600873 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/07/20New drug · Class 1 BAY 3713372 片 · No verified English nameCXHL2600872 Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized
2026/07/18Generic · Class 3 枸橼酸铁片 · No verified English nameCYHS2601721 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2026/07/18New drug · Class 1 注射用依康坦博妥塔单抗 · No verified English nameCXSS2600109 Shanghai Yi Lian Biopharmaceuticals Co., Ltd. romanized; Name not romanized
2026/07/18New drug · Class 2.4 瑞维鲁胺片 · No verified English nameCXHL2600871 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/07/18New drug · Class 1 注射用JZ1108i聚合物胶束 · No verified English nameCXHL2600870 Name not 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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