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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 300 drug applications between 20 July 2025 and 26 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 62 drug names.

2025/07/20 – 2025/07/26

Period
2025/07/20 to 2025/07/26, 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
300
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
70

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

300filings, 84 of them generic

By application type

Application typeFilings
Supplement128
Generic84
New drug56
Import24
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug205
TCM51
Therapeutic biologic38
Prophylactic biologic4
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets4220
2Tranexamic Acid Injection3111
3Ruxolitinib Phosphate Tablets3127
4Glucosamine Sulfate Capsules2251
5Propofol Medium And Long Chain Fat Emulsion Injection213
6Lidocaine and Prilocaine Cream2124
7Fruquintinib Capsules214
8复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
9Doxofylline Tablets212
10Doxycycline Hyclate for Injection2111

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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Yunnan Jin Bi Pharmaceutical Co., Ltd. romanized660
2AbbVie Inc.610
3Eli Lilly and Company610
4Shandong Er Ye Pharmaceutical Co., Ltd. romanized522
5Henan Zhen Shi Bio Technology Co., Ltd. romanized520
6Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized430
7Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized430
8Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized410
9Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized410
10Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized410

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

102 this week

AcceptedDrugApplicants
2025/07/25Import · Class 1 MK-7240注射液 · No verified English nameJXSL2500132 Merck Sharp & Dahme LLC; Name not romanized
2025/07/25Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2500131 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/07/25Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2500130 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/07/25Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2500129 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/07/25Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2500128 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/07/25Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2500127 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/07/25Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2502697 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/07/25Generic · Class 3 Perospirone Hydrochloride TabletsCYHS2502696 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2025/07/25Generic · Class 3 注射用盐酸头孢替安/氯化钠注射液 · No verified English nameCYHS2502693 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/25New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2500031 Guo Yao Group Guangdong Huan Qiu Pharmaceutical Co., Ltd. romanized
2025/07/25New drug · Class 2.3 欣力康胶囊 · No verified English nameCXZL2500054 Guiyang Xin Tian Pharma Co., Ltd. romanized
2025/07/25New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSS2500077 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized
2025/07/25New drug · Class 2.2 贝莫苏拜单抗注射液 · No verified English nameCXSL2500624 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/07/25New drug · Class 1 注射用JS107 · No verified English nameCXSL2500623 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/25New drug · Class 1 注射用HDM2017 · No verified English nameCXSL2500622 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2025/07/25New drug · Class 1 注射用JS207 · No verified English nameCXSL2500621 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/25New drug · Class 1 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2500620 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/07/25New drug · Class 1 注射用HLX43 · No verified English nameCXSL2500619 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/07/25New drug · Class 3.3 罗莫佐单抗注射液 · No verified English nameCXSL2500618 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized
2025/07/25New drug · Class 1 注射用JS207 · No verified English nameCXSL2500617 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/25New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2500616 Beijing Bai Hui Bio Technology Co., Ltd. romanized; Bo Hui Biopharmaceutical Co., Ltd. romanized
2025/07/25New drug · Class 1 注射用GD-11 · No verified English nameCXHS2500085 Jiangsu Vanguard Pharmaceutical Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/07/25New drug · Class 2.4 注射用紫杉醇阳离子脂质体 · No verified English nameCXHL2500760 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/07/25New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2500759 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/07/25New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2500758 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/07/25New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2500757 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/07/25New drug · Class 1 WJB001胶囊 · No verified English nameCXHL2500756 Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/07/24Import · Class 2.1 ASP5541注射液 · No verified English nameJXHL2500200 Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd.
2025/07/24Generic · Class 3 盐酸丙卡特罗干糖浆 · No verified English nameCYHS2502690 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/07/24Generic · Class 3 Ebastine Oral SolutionCYHS2502684 Jiangsu Vanguard Pharmaceutical Co., Ltd.

72 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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