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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 671 drug applications between 11 October 2025 and 17 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 116, covering 89 drug names.

2025/10/11 – 2025/10/17

Period
2025/10/11 to 2025/10/17, 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
671
Drugs with new generic filings (by drug name, de-duplicated)
89
Accepted this week, now under review
143

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

671filings, 116 of them generic

By application type

Application typeFilings
Supplement357
New drug134
Generic116
Unspecified30
Import26
Import re-registration8

By drug type

Drug typeFilings
Chemical drug407
TCM143
Therapeutic biologic89
Biologic21
Prophylactic biologic8
Unspecified3

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

89 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Glucosamine Sulfate Capsules4451
2Vonoprazan Fumarate Tablets4260
3Sacubitril Valsartan Sodium Tablets3270
4Ambroxol Hydrochloride Oral Solution3246
5甘油灌肠剂 · No verified English name312
6甲苯磺酸卢美哌隆胶囊 · No verified English name312
7LevomilnacipranHydrochloride Extended-release Capsules316
8达普司他片 · No verified English name310
9Pemafibrate Tablets2223
10磷酸奥司他韦颗粒 · No verified English name2212

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

342 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized66490
2Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized1020
3AstraZeneca AB840
4Qilu Pharmaceutical Co., Ltd.843
5Actelion Pharmaceuticals Ltd810
6Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized770
7Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized770
8Zhongshan Wanhan Pharmaceuticals Co., Ltd.732
9Wyeth Pharmaceutical Division of Wyeth Holdings LLC660
10Jilin Fei Nuo 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

202 this week

AcceptedDrugApplicants
2025/10/17Import · Class 1 Duvakitug注射液 · No verified English nameJXSL2500202 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/10/17Generic · Class 3 Digoxin InjectionCYHS2503725 Henan Pu Rui Pharma Co., Ltd. romanized
2025/10/17Generic · Class 3 Digoxin InjectionCYHS2503724 Henan Pu Rui Pharma Co., Ltd. romanized
2025/10/17Generic · Class 3 多种微量元素注射液(Ι) · No verified English nameCYHS2503721 Wei Sheng Yuan (Xiamen) Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/10/17Generic · Class 3 醋酸锌颗粒 · No verified English nameCYHS2503719 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/10/17Generic · Class 3 醋酸锌颗粒 · No verified English nameCYHS2503718 Sichuan Kelun Pharmaceutical Co., Ltd.
2025/10/17New drug · Class 2.1 TFA003片 · No verified English nameCXZL2500101 Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized
2025/10/17New drug · Class 1 注射用BG-C9074 · No verified English nameCXSL2500904 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/10/17New drug · Class 1 IM19嵌合抗原受体T细胞注射液(IM19 CAR-T细胞注射液) · No verified English nameCXSL2500903 Shandong Jin Sai Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 INS19嵌合抗原受体T细胞注射液(INS19 CAR-T细胞注射液) · No verified English nameCXSL2500902 Shandong Jin Sai Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 INS19嵌合抗原受体T细胞注射液(INS19 CAR-T细胞注射液) · No verified English nameCXSL2500901 Shandong Jin Sai Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 MIL116注射液 · No verified English nameCXSL2500900 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 3.3 艾美赛珠单抗注射液 · No verified English nameCXSL2500899 Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized
2025/10/17New drug · Class 1.2 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500898 Jiangsu Li Wei Si De Bio Technology Co., Ltd. romanized; Li Wei Si De Bio Technology (Shanghai) Co., Ltd. romanized
2025/10/17New drug · Class 3.3 艾美赛珠单抗注射液 · No verified English nameCXSL2500897 Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized
2025/10/17New drug · Class 1 SHR-7787 注射液 · No verified English nameCXSL2500896 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/10/17New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500895 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/10/17New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2500894 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/10/17New drug · Class 1 AGA2115注射液 · No verified English nameCXSL2500893 An Ji Sheng Biopharmaceuticals Technology (Guangzhou) Co., Ltd. romanized
2025/10/17New drug · Class 1 BG-75202片 · No verified English nameCXHL2501141 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 BG-75202片 · No verified English nameCXHL2501140 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 BG-75202片 · No verified English nameCXHL2501139 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/10/17New drug · Class 1 EP-0226片 · No verified English nameCXHL2501137 Chengdu Easton Biopharmaceuticals Co.,Ltd.; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized
2025/10/17New drug · Class 1 EP-0226片 · No verified English nameCXHL2501136 Chengdu Easton Biopharmaceuticals Co.,Ltd.; Zhongguo Ke College Shanghai Drug Research Institute romanized; Zhong Ke Zhong Shan Drug Innovation Research Institute romanized
2025/10/17New drug · Class 2.2 特立帕肽注射液 · No verified English nameCXHL2501135 Yunnan Xian Shi Pharma Co., Ltd. romanized
2025/10/17New drug · Class 1 注射用BH1621 · No verified English nameCXHL2501134 Zhuhai Bei Hai Bio Technology Co., Ltd. romanized
2025/10/16Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2500133 Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/16Import · Class 3.1 瑞利珠单抗注射液 · No verified English nameJXSS2500132 Alexion Europe SAS; Alexion Pharma International Operations Limited; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/16Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSL2500201 Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.
2025/10/16Import · Class 2.4 KarXT胶囊 · No verified English nameJXHL2500320 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.

172 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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