YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 555 drug applications between 22 December 2025 and 28 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 128, covering 83 drug names.

2025/12/22 – 2025/12/28

Period
2025/12/22 to 2025/12/28, 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
555
Drugs with new generic filings (by drug name, de-duplicated)
83
Accepted this week, now under review
134

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

555filings, 128 of them generic

By application type

Application typeFilings
Supplement246
Generic128
New drug128
Import20
Import re-registration17
Unspecified16

By drug type

Drug typeFilings
Chemical drug330
TCM110
Therapeutic biologic100
Biologic7
Prophylactic biologic7
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

83 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

311 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
9Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized532
10Name not 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

187 this week

AcceptedDrugApplicants
2025/12/27Import · Class 1 Iberdomide胶囊 · No verified English nameJXHS2500139 Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/12/27Import · Class 1 Iberdomide胶囊 · No verified English nameJXHS2500138 Bristol-Myers Squibb Pharma EEIG; Celgene International Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/12/27Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504440 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized
2025/12/27Generic · Class 3 Topiroxostat TabletsCYHL2500232 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2025/12/27Generic · Class 3 Topiroxostat TabletsCYHL2500231 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2025/12/27New drug · Class 1 IBI3028 · No verified English nameCXSL2501150 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2025/12/27New drug · Class 1 注射用ACT100 · No verified English nameCXSL2501149 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2025/12/27New drug · Class 1 注射用ACT100 · No verified English nameCXSL2501148 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2025/12/27New drug · Class 1 JMB2202注射液 · No verified English nameCXSL2501147 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized
2025/12/27New drug · Class 1 RC148注射液 · No verified English nameCXSL2501146 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2025/12/27New drug · Class 1 GV20-0251注射液 · No verified English nameCXSL2501145 Shanghai Xun Bai Hui Bio Technology Co., Ltd. romanized
2025/12/27New drug · Class 1 YHL-2101注射液 · No verified English nameCXSL2501144 Shanghai Hai Lu Bio Technology Co., Ltd. romanized; Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Hai Bo Biopharmaceutical Co., Ltd. romanized
2025/12/27New drug · Class 1 HSK50042片 · No verified English nameCXHL2501482 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/12/27New drug · Class 1 HSK50042片 · No verified English nameCXHL2501481 Shanghai Hai Si Sheng Nuo Pharmaceuticals Technology Co., Ltd. romanized
2025/12/27New drug · Class 1 EGFNASA软膏 · No verified English nameCXHL2501480 Ningbo Ai Ke Suo Pharmaceuticals Technology Co., Ltd. romanized
2025/12/27New drug · Class 1 EGFNASA软膏 · No verified English nameCXHL2501479 Ningbo Ai Ke Suo Pharmaceuticals Technology Co., Ltd. romanized
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

157 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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