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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 306 drug applications between 14 December 2025 and 20 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 54, covering 35 drug names.

2025/12/14 – 2025/12/20

Period
2025/12/14 to 2025/12/20, 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
306
Drugs with new generic filings (by drug name, de-duplicated)
35
Accepted this week, now under review
71

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

306filings, 54 of them generic

By application type

Application typeFilings
Supplement177
New drug62
Generic54
Import5
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug152
TCM100
Therapeutic biologic52
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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mirogabalin Besilate Tablets4161
2Finerenone Tablets3269
3Lidocaine and Prilocaine Cream3124
4Sildenafil Citrate Tablets3112
5Nystatin Oral Suspension223
6Divalproex Sodium Extended-Release Tablets210
7Cefditoren Pivoxil Granules2118
8Losartan Potassium Tablets215
9Loxoprofen Sodium Patches2130
10Safinamide Methansulfonate Tablets2120

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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng De Shang Pharma Co., Ltd. romanized23220
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized990
3Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized830
4Novo Nordisk A/S820
5Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized640
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Beijing Lian Er Tang Pharma Co., Ltd. romanized440
8Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized440
9Pfizer Inc.420
10Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized420

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

80 this week

AcceptedDrugApplicants
2025/12/19Import · Class 1 人源化抗BTN1A1单克隆抗体 · No verified English nameJXSL2500242 STCube Inc.; Beijing Wei Li Fang Biotechnology Co. Ltd.
2025/12/19Generic · Class 3 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2504316 Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized
2025/12/19New drug · Class 1.1 GPN01020胶囊 · No verified English nameCXZL2500132 Yuan Da Bei Lin (Xian) Pharma Co., Ltd. romanized; En Shi Tu Jia Zu Miao Zu Zi Zhi Zhou Center Hospital romanized
2025/12/19New drug · Class 1.1 益肺散结丸 · No verified English nameCXZL2500131 Guangzhou Zhong Pharmaceuticals University Di Yi Fu Shu Hospital romanized
2025/12/19New drug · Class 1 维拉西塔单抗注射液 · No verified English nameCXSS2500142 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2025/12/19New drug · Class 1 注射用BL-M11D1 · No verified English nameCXSL2501099 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/19New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2501098 Jiangsu Pu Rui Kang Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 SHR-1819注射液 · No verified English nameCXSL2501097 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/12/19New drug · Class 1 SHR-1905注射液 · No verified English nameCXSL2501096 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/12/19New drug · Class 3.3 SYS6053 · No verified English nameCXSL2501095 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/12/19New drug · Class 1 JMT206注射液 · No verified English nameCXSL2501094 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 注射用DR30206 · No verified English nameCXSL2501093 Zhejiang Dao Er Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 注射用IMM0306S · No verified English nameCXSL2501092 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2025/12/19New drug · Class 1 注射用HLX87 · No verified English nameCXSL2501091 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2025/12/19New drug · Class 1 替恩戈替尼片 · No verified English nameCXHS2500160 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/12/19New drug · Class 1 替恩戈替尼片 · No verified English nameCXHS2500159 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/12/19New drug · Class 1 替恩戈替尼片 · No verified English nameCXHS2500158 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2025/12/19New drug · Class 1 QLS1410片 · No verified English nameCXHL2501421 Qilu Pharmaceutical Co., Ltd.
2025/12/19New drug · Class 1 QLS1410片 · No verified English nameCXHL2501420 Qilu Pharmaceutical Co., Ltd.
2025/12/19New drug · Class 1 注射用PTT-936 · No verified English nameCXHL2501413 Beijing Yan Ming Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501412 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501411 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501410 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501409 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 RP-0172胶囊 · No verified English nameCXHL2501406 Li Bo (Shenzhen) Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 RP-0172胶囊 · No verified English nameCXHL2501405 Li Bo (Shenzhen) Bio Technology Co., Ltd. romanized
2025/12/19New drug · Class 1 RP-0172胶囊 · No verified English nameCXHL2501404 Li Bo (Shenzhen) Bio Technology Co., Ltd. romanized
2025/12/18Import · Class 2.2 TAK-755 · No verified English nameJXSL2500241 Takeda Development Center Americas Inc.
2025/12/18Generic · Class 3 磷酸奥司他韦颗粒 · No verified English nameCYHS2504308 Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
2025/12/18Generic · Class 3 Colistimethate Sodium for InjectionCYHL2500225 Tianjin Hong Ri Pharma Co., Ltd. romanized

50 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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