YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 319 drug applications between 26 July 2025 and 1 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 60 drug names.
2025/07/26 – 2025/08/01
- New acceptances this week
- 319
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 64
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
319filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 151 |
| Generic | 74 |
| New drug | 57 |
| Import | 26 |
| Import re-registration | 7 |
| Unspecified | 2 |
| Drug-device combination product | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 77 |
| Therapeutic biologic | 46 |
| Unspecified | 3 |
| Prophylactic biologic | 2 |
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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 2 | Omega-3-acid ethyl ester 90 Soft Capsules | 2 | 2 | 11 |
| 3 | Pemafibrate Tablets | 2 | 2 | 23 |
| 4 | Morinidazole and Sodium Chloride Injection | 2 | 2 | 9 |
| 5 | 头孢克肟干混悬剂 · No verified English name | 2 | 2 | 3 |
| 6 | Mecobalamin Tablets | 2 | 2 | 16 |
| 7 | 硝普钠氯化钠注射液 · No verified English name | 2 | 2 | 3 |
| 8 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 8 | 4 | 1 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 3 | 0 |
| 4 | Amgen Inc. | 6 | 3 | 0 |
| 5 | Henan Xin Xiang Hua Xing Pharmaceutical Factory romanized | 6 | 2 | 0 |
| 6 | Pharmathen International S.A. | 5 | 1 | 0 |
| 7 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 9 | Shandong Lukang Pharmaceutical Co.,Ltd. | 4 | 2 | 2 |
| 10 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/01Import · Class 2.1 | 艾沙妥昔单抗注射液(皮下注射) · No verified English nameJXSS2500107 | Sanofi Winthrop Industrie; Sanofi-Aventis Deutschland GmbH |
| 2025/08/01Generic · Class 3 | 辅酶Q??片 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2502770 | Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/08/01Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2502768 | Zhuhai Heng Qin Guo Yan Pharmaceuticals Technology Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/08/01Generic · Class 3 | Amisulpride Oral SolutionCYHS2502767 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2025/08/01New drug · Class 1 | 注射用TQB2103 · No verified English nameCXSL2500643 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/08/01New drug · Class 1.2 | 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2500642 | Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized |
| 2025/08/01New drug · Class 1.2 | 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2500641 | Yunnan Wo Sen Bio Technology Co., Ltd. romanized; Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized |
| 2025/08/01New drug · Class 1 | 注射用7MW4911 · No verified English nameCXSL2500640 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2025/08/01New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2500791 | Shanxi Jia Yuan Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/01New drug · Class 1 | SA1211注射液 · No verified English nameCXHL2500790 | Suzhou Shi An Bio Technology Co., Ltd. romanized; Beijing Si Yuan Rui An Bio Technology Co., Ltd. romanized |
| 2025/08/01New drug · Class 2.2 | BIFC胶囊装微片 · No verified English nameCXHL2500789 | Beijing Tian Heng Drug Research Institute Co., Ltd. romanized |
| 2025/08/01New drug · Class 2.2 | BIFC胶囊装微片 · No verified English nameCXHL2500788 | Beijing Tian Heng Drug Research Institute Co., Ltd. romanized |
| 2025/08/01New drug · Class 1 | ADC118片 · No verified English nameCXHL2500787 | Chengdu Ai Di Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Nanjing Ai Di Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/08/01New drug · Class 2.2 | VHDT口崩片 · No verified English nameCXHL2500786 | Fuzhou Zhang Fu Xing Biopharmaceuticals Technology Co., Ltd. romanized; Xiamen En Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/07/31Import · Class 1 | Icotrokinra片 · No verified English nameJXHL2500208 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/07/31Import · Class 1 | Icotrokinra片 · No verified English nameJXHL2500207 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/07/31Import · Class 1 | LOU064片 · No verified English nameJXHL2500206 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2025/07/31Generic · Class 3 | 硝普钠氯化钠注射液 · No verified English nameCYHS2502762 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Jiangsu Chang Jiang Pharma Co., Ltd. romanized |
| 2025/07/31Generic · Class 3 | 头孢克肟干混悬剂 · No verified English nameCYHS2502761 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized |
| 2025/07/31Generic · Class 3 | 头孢克肟干混悬剂 · No verified English nameCYHS2502757 | Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized |
| 2025/07/31New drug · Class 1.1 | 益母妇炎颗粒 · No verified English nameCXZL2500058 | Jian Min Pharma Group Co., Ltd. romanized |
| 2025/07/31New drug · Class 3.2 | 注射用罗普司亭N01 · No verified English nameCXSL2500639 | Qilu Pharmaceutical Co., Ltd. |
| 2025/07/31New drug · Class 3.2 | 注射用罗普司亭N01 · No verified English nameCXSL2500638 | Qilu Pharmaceutical Co., Ltd. |
| 2025/07/31New drug · Class 1 | 人源多巴胺能前体细胞注射液 · No verified English nameCXSL2500637 | Rui Jian Yi Lian Pharmaceuticals Technology (Chengdu) Co., Ltd. romanized; Rui Jian Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2025/07/31New drug · Class 1 | EA5注射液皮下制剂 · No verified English nameCXSL2500635 | Shanghai Lan Yi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/31New drug · Class 2.2 | 依达拉奉片 · No verified English nameCXHS2500088 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2025/07/31New drug · Class 2.1; 2.2; 2.4 | 注射用ADB116 · No verified English nameCXHL2500785 | Jiangsu Ai Di Pharma Group Co., Ltd. romanized; Nanjing Nan Da Pharma Co., Ltd. romanized |
| 2025/07/31New drug · Class 1 | HSK42360-Na散 · No verified English nameCXHL2500784 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/07/31New drug · Class 1 | HSK42360-Na散 · No verified English nameCXHL2500783 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/07/30Import · Class 3.1 | 注射用塔拉妥单抗 · No verified English nameJXSS2500105 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
63 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.