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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 490 drug applications between 12 June 2025 and 18 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 134, covering 99 drug names.

2025/06/12 – 2025/06/18

Period
2025/06/12 to 2025/06/18, 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
490
Drugs with new generic filings (by drug name, de-duplicated)
99
Accepted this week, now under review
73

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

490filings, 134 of them generic

By application type

Application typeFilings
Supplement201
Generic134
New drug75
Import59
Unspecified10
Import re-registration10
Medical device (joint review)1

By drug type

Drug typeFilings
Chemical drug300
Therapeutic biologic96
TCM82
Biologic7
Prophylactic biologic3
In vitro diagnostic reagent1
Unspecified1

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

99 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection111153
2苯磺酸左氨氯地平片 · No verified English name4245
3Escitalopram Oxalate Tablets316
4Upadacitinib Sustained-release Tablets2243
5Peramivir Injection227
6托吡酯口服溶液 · No verified English name227
7Acetylcysteine Oral Solution2111
8Lactulose Oral Solution2134
9Carbidopa and Levodopa Sustained-release Tablets212
10Perindopril tert-Butylamine Tablets215

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

293 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Merck Sharp & Dohme B.V.2210
2Henan Ying Feng Pharmaceuticals Co., Ltd. romanized880
3Pfizer Inc.830
4Amgen Inc.820
5Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized770
6Novo Nordisk A/S720
7Rui Yang Pharmaceutical Co., Ltd. romanized720
8Name not romanized640
9AstraZeneca AB630
10Shijiazhuang No.4 Pharmaceutical Co., Ltd.554

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

174 this week

AcceptedDrugApplicants
2025/06/18Import · Class 2.2 DS-1062a · No verified English nameJXSL2500102 Daiichi Sankyo Inc.
2025/06/18Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2500101 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/06/18Import · Class 2.2 比奇珠单抗注射液 · No verified English nameJXSL2500100 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2025/06/18Import · Class 2.2 比奇珠单抗注射液 · No verified English nameJXSL2500099 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2025/06/18Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2500098 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/06/18Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2500097 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.?
2025/06/18Import · Class 1 PF-07248144片 · No verified English nameJXHL2500149 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/18Import · Class 1 PF-07248144片 · No verified English nameJXHL2500148 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/18Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2502194 Guangzhou Han Guang Pharma Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2025/06/18Generic · Class 3 Sodium Thiosulfate InjectionCYHS2502193 Zhong Run Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2025/06/18Generic · Class 3 Sodium Thiosulfate InjectionCYHS2502192 Zhong Run Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2025/06/18Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2502188 Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Peramivir InjectionCYHS2502187 Hainan Hui Pu Sen Pharmaceuticals Bio Technology Co., Ltd. romanized
2025/06/18Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2502186 Hainan Yun Ding Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2502182 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/06/18Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2502177 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2502176 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502175 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2025/06/18Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2502174 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/06/18Generic · Class 3 Bilastine Oral SolutionCYHS2502169 Henan Jun Shan Bio Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2025/06/18New drug · Class 3.3 雷珠单抗注射液 · No verified English nameCXSS2500067 Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized
2025/06/18New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) (复合佐剂) · No verified English nameCXSL2500498 Jiangsu Li Wei Si De Bio Technology Co., Ltd. romanized; Li Wei Si De Bio Technology (Shanghai) Co., Ltd. romanized
2025/06/18New drug · Class 1 SA102-CAR-T注射液 · No verified English nameCXSL2500497 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/06/18New drug · Class 1 JLM019注射液 · No verified English nameCXSL2500496 Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized; Jie Ke (Tianjin) Biopharmaceuticals Co., Ltd. romanized
2025/06/18New drug · Class 1 KN5501细胞注射液 · No verified English nameCXSL2500488 Shenzhen En Rui Kai Nuo Bio Technology Co., Ltd. romanized
2025/06/18New drug · Class 1 F-02-2-Na片 · No verified English nameCXHL2500589 Guangdong Heng Qin Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized; Guangzhou Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized
2025/06/18New drug · Class 1 F-02-2-Na片 · No verified English nameCXHL2500588 Guangdong Heng Qin Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized; Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized; Guangzhou Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized
2025/06/18New drug · Class 1 F-02-2-Na片 · No verified English nameCXHL2500587 Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized; Guangzhou Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized; Guangdong Heng Qin Xin Chuang Yi Biopharmaceuticals Co., Ltd. romanized
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500096 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2025/06/17Import · Class 1 AMG 133 · No verified English nameJXSL2500095 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.

144 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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