YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 336 drug applications between 15 July 2025 and 21 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 80 drug names.

2025/07/15 – 2025/07/21

Period
2025/07/15 to 2025/07/21, 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
336
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
65

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

336filings, 99 of them generic

By application type

Application typeFilings
Supplement148
Generic99
New drug58
Import12
Unspecified10
Import re-registration9

By drug type

Drug typeFilings
Chemical drug233
TCM57
Therapeutic biologic30
Prophylactic biologic11
Biologic5

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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
2Upadacitinib Sustained-release Tablets2243
3Acetylcysteine Injection2253
4甘油磷酸钠注射液 · No verified English name227
5维生素K1滴剂 · No verified English name223
6Voriconazole Tablets211
7低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name213
8低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name214
9低钙腹膜透析液(乳酸盐-G4.25%) · No verified English name213
10呋喃妥因胶囊 · No verified English name214

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

214 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Qing Feng Pharma Co., Ltd. romanized880
2Beijing Min Hai Bio Technology Co., Ltd. romanized650
3Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized636
4Bracco Imaging S.P.A.610
5Ningbo Tian Yi Pharma Technology Co., Ltd. romanized555
6Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized550
7Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized510
8Revance Therapeutics Inc.440
9Zhu Zhou Qian Jin Pharma Co., Ltd. romanized440
10CSPC OUYI PHARMACEUTICAL CO., LTD.423

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

105 this week

AcceptedDrugApplicants
2025/07/21New drug · Class 1.1 重组金黄色葡萄球菌四组分疫苗(大肠杆菌) · No verified English nameCXSL2500611 Jiangsu Kun Li Biopharmaceutical Co., Ltd. romanized
2025/07/21New drug · Class 3.2 三价流感病毒裂解疫苗(BK-01佐剂) · No verified English nameCXSL2500608 Changchun Bai Ke Bio Technology Shareholding Company romanized
2025/07/21New drug · Class 1 CMS-D002胶囊 · No verified English nameCXHL2500728 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/07/21New drug · Class 1 CMS-D002胶囊 · No verified English nameCXHL2500727 Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized
2025/07/19Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2502610 Shandong Hua Mao Pharma Co., Ltd. romanized
2025/07/19Generic · Class 3 吲哚美辛凝胶贴膏 · No verified English nameCYHL2500130 Hainan Hui Yuan Tang Pharma Co., Ltd. romanized
2025/07/19New drug · Class 2.2 AKZ001直服颗粒 · No verified English nameCXHL2500726 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500725 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500724 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500723 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500722 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 CKBA乳膏 · No verified English nameCXHL2500721 Jiangsu Bo Chuang Yuan Biopharmaceuticals Technology Co., Ltd. romanized
2025/07/19New drug · Class 1 YUQ-A1007片 · No verified English nameCXHL2500720 Yuan Qi (Suzhou) Biopharmaceutical Co., Ltd. romanized
2025/07/19New drug · Class 1 YUQ-A1007片 · No verified English nameCXHL2500719 Yuan Qi (Suzhou) Biopharmaceutical Co., Ltd. romanized
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

75 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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