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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 516 drug applications between 20 December 2025 and 26 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 78 drug names.

2025/12/20 – 2025/12/26

Period
2025/12/20 to 2025/12/26, 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
516
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
119

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

516filings, 114 of them generic

By application type

Application typeFilings
Supplement237
New drug117
Generic114
Import17
Import re-registration17
Unspecified14

By drug type

Drug typeFilings
Chemical drug300
TCM109
Therapeutic biologic93
Prophylactic biologic7
Biologic6
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

78 drugs with new generic filings; top 10 listed

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

290 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng De Shang Pharma Co., Ltd. romanized23170
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized16160
3Amgen Inc.1320
4AstraZeneca AB1170
5Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized910
6medac Gesellschaft für klinische Spezialpr?parate mbH810
7Merck Sharp & Dohme LLC740
8Hunan Jiudian Pharmaceutical Co., Ltd651
9Name not romanized520
10A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized520

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

171 this week

AcceptedDrugApplicants
2025/12/26Generic · Class 3 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2504437 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/12/26Generic · Class 3 Acetylcysteine Oral SolutionCYHS2504423 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/12/26Generic · Class 3 Acetylcysteine Oral SolutionCYHS2504422 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/12/26Generic · Class 3 Acetylcysteine Oral SolutionCYHS2504421 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2025/12/26Generic · Class 3 Acetylcysteine Oral SolutionCYHS2504420 Chengdu Bai Teng Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2025/12/26Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2504418 Hua Zhong Pharma Co., Ltd. romanized
2025/12/26Generic · Class 3 Netilmicin Sulfate InjectionCYHS2504415 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/12/26Generic · Class 3 氯雷他定口服溶液 · No verified English nameCYHS2504410 Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/12/26Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2504409 Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized
2025/12/26Generic · Class 3 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2504407 Guangdong Ke Hong Pharma Co., Ltd. romanized
2025/12/26New drug · Class 1.1 九味合欢颗粒 · No verified English nameCXZL2500135 Ningbo Jiu Rui Pharma Co., Ltd. romanized
2025/12/26New drug · Class 1 注射用经应激诱导的间充质干细胞衍生物 · No verified English nameCXSL2501153 Da Er Wen Qi Dian (Hubei) Biopharmaceutical Co., Ltd. romanized
2025/12/26New drug · Class 1 舒西利单抗注射液 · No verified English nameCXSL2501143 Zhong Kang Biopharmaceutical (Haikou) Co., Ltd. romanized
2025/12/26New drug · Class 1 CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2501142 Guangzhou Sai Juan Bio Technology Co., Ltd. romanized
2025/12/26New drug · Class 1 DXP-106注射液 · No verified English nameCXSL2501141 Zhuhai Dan Xu Biopharmaceutical Co., Ltd. romanized
2025/12/26New drug · Class 1 脂肪间充质干细胞注射液 · No verified English nameCXSL2501140 Guangdong Sai Er Bio Technology Co., Ltd. romanized
2025/12/26New drug · Class 1 PM8102注射用冻干制剂 · No verified English nameCXSL2501139 Zhuhai Pu Mi Si Bio Technology Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2025/12/26New drug · Class 1.2 重组三价轮状病毒亚单位疫苗(大肠埃希菌) · No verified English nameCXSL2501136 Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized; Xiamen University romanized
2025/12/26New drug · Class 1 JSKN033注射液 · No verified English nameCXSL2501135 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2025/12/26New drug · Class 1 注射用HLX316 · No verified English nameCXSL2501134 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/12/26New drug · Class 2.4 赛沃替尼片 · No verified English nameCXHS2500165 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2025/12/26New drug · Class 2.4 赛沃替尼片 · No verified English nameCXHS2500164 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized
2025/12/26New drug · Class 2.2 HY22017胶囊 · No verified English nameCXHS2500163 Changchun Hai Yue Pharma Co., Ltd. romanized
2025/12/26New drug · Class 1 68-218注射液 · No verified English nameCXHL2501478 Chongqing A Pu Ge Lei Bio Technology Co., Ltd. romanized
2025/12/26New drug · Class 1 注射用INV-8989 · No verified English nameCXHL2501477 Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized
2025/12/26New drug · Class 2.2; 2.4 MI151凝胶 · No verified English nameCXHL2501476 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/12/26New drug · Class 2.2; 2.4 MI151凝胶 · No verified English nameCXHL2501475 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2025/12/26New drug · Class 1 注射用GGA-sNIR · No verified English nameCXHL2501474 Guangzhou Shi Yun Bio Technology Co., Ltd. romanized
2025/12/26New drug · Class 2.2 BN114731 · No verified English nameCXHL2501473 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2025/12/26New drug · Class 1 注射用富马酸赛诺拉赞 · No verified English nameCXHL2501472 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized

141 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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