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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 515 drug applications between 9 October 2025 and 15 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 82 drug names.

2025/10/09 – 2025/10/15

Period
2025/10/09 to 2025/10/15, 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
515
Drugs with new generic filings (by drug name, de-duplicated)
82
Accepted this week, now under review
123

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

515filings, 103 of them generic

By application type

Application typeFilings
Supplement243
New drug112
Generic103
Unspecified24
Import24
Import re-registration9

By drug type

Drug typeFilings
Chemical drug305
TCM109
Therapeutic biologic74
Biologic18
Prophylactic biologic6
Unspecified2
In vitro diagnostic reagent1

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

82 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ambroxol Hydrochloride Oral Solution3246
2甘油灌肠剂 · No verified English name312
3甲苯磺酸卢美哌隆胶囊 · No verified English name312
4达普司他片 · No verified English name310
5Pemafibrate Tablets2223
6Furosemide Injection226
7Vortioxetine Hydrobromide Tablets2210
8磷酸奥司他韦颗粒 · No verified English name2212
9复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
10Dotinurad Tablets2155

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

285 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized21150
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1020
3AstraZeneca AB940
4Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized840
5Bristol-Myers Squibb Company820
6Actelion Pharmaceuticals Ltd810
7Wyeth Pharmaceutical Division of Wyeth Holdings LLC660
8Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized660
9Ai Min Pharma Group Co., Ltd. romanized660
10Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized660

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
2025/10/15Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2500200 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/10/15Import · Class 1 AZD0486 · No verified English nameJXSL2500199 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/15Import · Class 1 AZD0486 · No verified English nameJXSL2500198 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/15Generic · Class 3 Olopatadine Hydrochloride GranulesCYHS2503688 Zhuhai Tong Yuan Pharma Co., Ltd. romanized
2025/10/15Generic · Class 3 比拉斯汀口崩片 · No verified English nameCYHS2503686 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/10/15Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2503683 Hebei Shan Mu Shi Pharma Co., Ltd. romanized
2025/10/15Generic · Class 3 Dequalinium Chloride Buccal TabletsCYHS2503682 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2025/10/15Generic · Class 3 注射用氨曲南/氯化钠注射液 · No verified English nameCYHS2503681 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/10/15Generic · Class 3 注射用氨曲南/氯化钠注射液 · No verified English nameCYHS2503680 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/10/15Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L) · No verified English nameCYHS2503679 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/10/15Generic · Class 3 碳酸氢钠血滤置换液(无钾) · No verified English nameCYHS2503677 Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized
2025/10/15Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2503675 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/10/15Generic · Class 3 达普司他片 · No verified English nameCYHL2500186 NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2025/10/15Generic · Class 3 达普司他片 · No verified English nameCYHL2500185 NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2025/10/15Generic · Class 3 达普司他片 · No verified English nameCYHL2500184 NORTH CHINA PHARMACEUTICAL COMPANY.LTD
2025/10/15New drug · Class 1.2 LC提取物 · No verified English nameCXZL2500100 Zhongguo Ke College Hangzhou Yi Xue Research Institute romanized
2025/10/15New drug · Class 1.2 LC肠溶胶囊 · No verified English nameCXZL2500099 Zhongguo Ke College Hangzhou Yi Xue Research Institute romanized
2025/10/15New drug · Class 1.1 连冰喷雾剂 · No verified English nameCXZL2500098 Zhuo He Pharma Group Co., Ltd. romanized
2025/10/15New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2500114 Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized
2025/10/15New drug · Class 2.2 贝伐珠单抗眼内注射溶液 · No verified English nameCXSS2500113 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2025/10/15New drug · Class 3.3 13价肺炎球菌多糖结合疫苗 · No verified English nameCXSS2500107 Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/10/15New drug · Class 1 CM512注射液 · No verified English nameCXSL2500889 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/10/15New drug · Class 1 CM512注射液 · No verified English nameCXSL2500888 Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized
2025/10/15New drug · Class 1 人脐带源间充质干细胞注射液 · No verified English nameCXSL2500887 Pu Hua Sai Er Bio Medical Technology Co., Ltd. romanized
2025/10/15New drug · Class 1 YX3D-01 人脐带间充质干细胞注射液 · No verified English nameCXSL2500886 Yi Xing Pharmaceuticals Research and Development (Qin Huang Dao Bei Dai He Qu) Co., Ltd. romanized
2025/10/15New drug · Class 1 注射用HX111 · No verified English nameCXSL2500885 Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2025/10/15New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2500884 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/10/15New drug · Class 1 SIG001注射液 · No verified English nameCXSL2500883 Guangzhou Ai Sai Ji Biopharmaceuticals Technology Co., Ltd. romanized
2025/10/15New drug · Class 1 XS411细胞注射液 · No verified English nameCXSL2500882 Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized; Shi Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2025/10/15New drug · Class 1 注射用SHR-A2102 · No verified English nameCXSL2500881 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized

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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