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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 405 drug applications between 12 July 2025 and 18 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 125, covering 94 drug names.

2025/07/12 – 2025/07/18

Period
2025/07/12 to 2025/07/18, 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
405
Drugs with new generic filings (by drug name, de-duplicated)
94
Accepted this week, now under review
79

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

405filings, 125 of them generic

By application type

Application typeFilings
Supplement164
Generic125
New drug83
Import19
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug271
TCM76
Therapeutic biologic47
Prophylactic biologic10
Biologic1

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

94 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1复方电解质醋酸钠葡萄糖注射液 · No verified English name4222
2Minoxidil Liniment4252
3Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
4Acetylcysteine Injection2253
5瑞维那新吸入溶液 · No verified English name2253
6甘油磷酸钠注射液 · No verified English name227
7Nicardipine Hydrochloride Injection2213
8维生素K1滴剂 · No verified English name223
9Cimetidine Injection225
10Voriconazole Tablets211

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

251 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized12612
2Jiangxi Qing Feng Pharma Co., Ltd. romanized880
3Beijing Min Hai Bio Technology Co., Ltd. romanized650
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized650
5Bracco Imaging S.P.A.610
6Ningbo Tian Yi Pharma Technology Co., Ltd. romanized555
7Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized550
8AstraZeneca AB520
9Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized440
10Zhu Zhou Qian Jin Pharma Co., Ltd. romanized440

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

154 this week

AcceptedDrugApplicants
2025/07/18Import · Class 1 BMS-986504片 · No verified English nameJXHL2500189 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Import · Class 1 BMS-986504片 · No verified English nameJXHL2500188 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Import · Class 1 BMS-986504片 · No verified English nameJXHL2500187 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(无钾、无钙、0.6 mmol/L镁) · No verified English nameCYHS2502596 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(无钾) · No verified English nameCYHS2502595 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L无钙) · No verified English nameCYHS2502592 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized
2025/07/18Generic · Class 3 Bumetanide InjectionCYHS2502591 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2025/07/18Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2502590 Hainan Pu Li Pharmaceutical Co., Ltd. romanized
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L) · No verified English nameCYHS2502589 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized
2025/07/18Generic · Class 3 碳酸氢钠血滤置换液(钾2mmol/L无钙) · No verified English nameCYHS2502587 Ningbo Tian Yi Pharma Technology Co., Ltd. romanized
2025/07/18Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2502586 Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/07/18Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502583 Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2025/07/18Generic · Class 3 头孢羟氨苄干混悬剂 · No verified English nameCYHS2502582 Suzhou Di San Pharmaceutical Factory Co., Ltd. romanized
2025/07/18Generic · Class 3 Clindamycin Palmitate Hydrochloride GranulesCYHS2502578 Anhui Pioneer Pharmaceutical Co., Ltd
2025/07/18Generic · Class 3 Isoniazid Oral SolutionCYHS2502577 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/07/18New drug · Class 3.2 人血管性血友病因子/凝血因子Ⅷ复合物 · No verified English nameCXSS2500076 Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized
2025/07/18New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2500075 Jiangsu Jin Di Ke Bio Technology Co., Ltd. romanized
2025/07/18New drug · Class 1 HiCM388注射液 · No verified English nameCXSL2500607 Ai Er Pu Zai Sheng Yi Xue Technology (Shenzhen) Co., Ltd. romanized
2025/07/18New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2500606 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/07/18New drug · Class 1 SHR-7787注射液 · No verified English nameCXSL2500605 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/18New drug · Class 1 SHR-7787 注射液 · No verified English nameCXSL2500604 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/18New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500603 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/07/18New drug · Class 1 SHR-1905注射液 · No verified English nameCXSL2500602 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/18New drug · Class 1 SHR-4849注射液 · No verified English nameCXSL2500601 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/07/18New drug · Class 1 JYP0061片 · No verified English nameCXHL2500718 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2025/07/18New drug · Class 1 JYP0061片 · No verified English nameCXHL2500717 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2025/07/18New drug · Class 1 JYP0061片 · No verified English nameCXHL2500716 Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized
2025/07/18New drug · Class 2.4 APG-2575片 · No verified English nameCXHL2500715 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2025/07/18New drug · Class 2.4 APG-2575片 · No verified English nameCXHL2500714 Suzhou Ya Sheng Pharma Co., Ltd. romanized
2025/07/18New drug · Class 2.4 APG-2575片 · No verified English nameCXHL2500713 Suzhou Ya Sheng Pharma Co., Ltd. romanized

124 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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