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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 401 drug applications between 8 October 2025 and 14 October 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 68 drug names.

2025/10/08 – 2025/10/14

Period
2025/10/08 to 2025/10/14, 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
401
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
96

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

401filings, 85 of them generic

By application type

Application typeFilings
Supplement206
Generic85
New drug70
Import19
Unspecified13
Import re-registration8

By drug type

Drug typeFilings
Chemical drug229
TCM99
Therapeutic biologic56
Biologic10
Prophylactic biologic4
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

68 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
4Pemafibrate Tablets2223
5Furosemide Injection226
6Vortioxetine Hydrobromide Tablets2210
7复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
8Dotinurad Tablets2155
9Paracetamol Tablets216
10枸橼酸西地那非口溶膜 · No verified English name218

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

232 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Qi Ke Pharma Co., Ltd. romanized21150
2Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized840
3Bristol-Myers Squibb Company820
4AstraZeneca AB730
5Wyeth Pharmaceutical Division of Wyeth Holdings LLC660
6Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized660
7Ai Min Pharma Group Co., Ltd. romanized660
8Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized550
9Shaanxi Sun Si Miao Gao Xin Pharmaceutical Co., Ltd. romanized550
10Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized540

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

117 this week

AcceptedDrugApplicants
2025/10/14Import · Class 1 AZD2936 · No verified English nameJXSL2500197 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2025/10/14Import · Class 1 Brivekimig注射液 · No verified English nameJXSL2500196 Sanofi-aventis recherche & développement; Sanofi (China) Investment Co. Ltd.
2025/10/14Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500315 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/14Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500314 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/14Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500313 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/14Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2500312 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/10/14Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2503670 Shandong Qidu Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2503669 Shandong Qidu Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503666 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2503664 Guangdong Nan Guo Pharma Co., Ltd. romanized
2025/10/14Generic · Class 3 甘油灌肠剂 · No verified English nameCYHS2503662 Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized
2025/10/14Generic · Class 3 甘油灌肠剂 · No verified English nameCYHS2503661 Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized
2025/10/14Generic · Class 3 甘油灌肠剂 · No verified English nameCYHS2503660 Hebei Jiu Hui Pharmaceuticals Zhi Zao Co., Ltd. romanized
2025/10/14Generic · Class 3 碳酸氢钠林格注射液(Ⅰ) · No verified English nameCYHS2503656 Shandong Qidu Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 环孢素口服溶液 · No verified English nameCYHS2503654 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/10/14Generic · Class 3 Temozolomide For InjectionCYHS2503653 Beijing SL Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2503650 Shandong Pu Rui Man Pharma Co., Ltd. romanized
2025/10/14Generic · Class 3 Ambroxol Hydrochloride DropsCYHS2503646 Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2025/10/14Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500183 Qilu Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500182 Qilu Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 甲苯磺酸卢美哌隆胶囊 · No verified English nameCYHL2500181 Qilu Pharmaceutical Co., Ltd.
2025/10/14Generic · Class 3 Colistimethate Sodium for InjectionCYHL2500180 Chengdu Tong De Pharma Co., Ltd. romanized
2025/10/14New drug · Class 1.1 七味防己黄芪颗粒 · No verified English nameCXZL2500097 Zheng Da Qing Chun Bao Pharma Co., Ltd. romanized
2025/10/14New drug · Class 1.2 百蕊提取物颗粒 · No verified English nameCXZL2500096 Yue Kang Pharma Group Co., Ltd. romanized
2025/10/14New drug · Class 1.2 百蕊提取物 · No verified English nameCXZL2500095 Yue Kang Pharma Group Co., Ltd. romanized
2025/10/14New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSS2500112 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/10/14New drug · Class 1 依达格鲁肽α注射液 · No verified English nameCXSS2500111 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2025/10/14New drug · Class 1 依达格鲁肽α注射液 · No verified English nameCXSS2500110 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2025/10/14New drug · Class 1 依达格鲁肽α注射液 · No verified English nameCXSS2500109 Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized
2025/10/14New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSS2500108 Yi Dao Bio Technology (Suzhou) Co., Ltd. romanized

87 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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