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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 366 drug applications between 22 July 2025 and 28 July 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 103, covering 76 drug names.

2025/07/22 – 2025/07/28

Period
2025/07/22 to 2025/07/28, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
366
Drugs with new generic filings (by drug name, de-duplicated)
76
Accepted this week, now under review
88

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

366filings, 103 of them generic

By application type

Application typeFilings
Supplement155
Generic103
New drug73
Import27
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug243
TCM71
Therapeutic biologic48
Biologic2
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

76 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapoxetine Hydrochloride Tablets6320
2Finerenone Tablets4269
3Tranexamic Acid Injection3111
4Ruxolitinib Phosphate Tablets3127
5Morinidazole and Sodium Chloride Injection229
6Glucosamine Sulfate Capsules2251
7Propofol Medium And Long Chain Fat Emulsion Injection213
8Lidocaine and Prilocaine Cream2124
9Fruquintinib Capsules214
10复方电解质醋酸钠葡萄糖注射液 · No verified English name2122

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

237 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

124 this week

AcceptedDrugApplicants
2025/07/28Generic · Class 3 Indobufen TabletsCYHS2502710 Chengdu Zong Lian Medical Health Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/07/28Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502705 Qingdao Rui Nai Medical Technology Co., Ltd. romanized
2025/07/28Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502704 Qingdao Rui Nai Medical Technology Co., Ltd. romanized
2025/07/28Generic · Class 3 Potassium Chloride InjectionCYHS2502703 Hebei Tian Cheng Pharma Co., Ltd. romanized
2025/07/28Generic · Class 3 丙氯拉嗪栓 · No verified English nameCYHL2500132 Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 1.2 HQY总黄酮胶囊 · No verified English nameCXZL2500057 Nanjing San Tong Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized; Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized; Nanjing Shi Zhong Hospital romanized
2025/07/28New drug · Class 1.2 HQY总黄酮提取物 · No verified English nameCXZL2500056 Nanjing San Tong Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized; Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized; Nanjing Shi Zhong Hospital romanized
2025/07/28New drug · Class 1.1 糖宁通络片 · No verified English nameCXZL2500055 Bai Ling Yu Xiu (Zhuhai) Pharmaceuticals Co., Ltd. romanized
2025/07/28New drug · Class 1 IBI354 · No verified English nameCXSL2500632 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2025/07/28New drug · Class 1 镥[177Lu]-BL-ARC001注射液 · No verified English nameCXSL2500631 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/07/28New drug · Class 2.2 LY01015注射液 · No verified English nameCXSL2500630 Shandong Bo An Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 2.2 LY01015注射液 · No verified English nameCXSL2500629 Shandong Bo An Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 1 注射用BA1301 · No verified English nameCXSL2500628 Shandong Bo An Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500627 Beijing Di Yi Bio Technology Kai Fa Co., Ltd. romanized
2025/07/28New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2500626 Hunan Mai Ji Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2500625 Hunan Mai Ji Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 2.2 拉莫三嗪干混悬剂 · No verified English nameCXHS2500087 Shanghai Ao Ke Yuan Pharmaceutical Co., Ltd. romanized
2025/07/28New drug · Class 2.2 拉莫三嗪干混悬剂 · No verified English nameCXHS2500086 Shanghai Ao Ke Yuan Pharmaceutical Co., Ltd. romanized
2025/07/28New drug · Class 1 BGB-53038胶囊 · No verified English nameCXHL2500768 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 1 BGB-53038胶囊 · No verified English nameCXHL2500767 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2500766 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2025/07/28New drug · Class 1 BGB-53038胶囊 · No verified English nameCXHL2500765 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/07/28New drug · Class 1 AL28979片 · No verified English nameCXHL2500764 Nanjing Ai De Cheng Pharmaceuticals Technology Co., Ltd. romanized
2025/07/28New drug · Class 1 TQB3217片 · No verified English nameCXHL2500763 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/07/28New drug · Class 1 TQB3217片 · No verified English nameCXHL2500762 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2025/07/28New drug · Class 2.3 HKGM-453 · No verified English nameCXHL2500761 Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized
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.

94 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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