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
- 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 type | Filings |
|---|---|
| Supplement | 164 |
| Generic | 125 |
| New drug | 83 |
| Import | 19 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 271 |
| TCM | 76 |
| Therapeutic biologic | 47 |
| Prophylactic biologic | 10 |
| Biologic | 1 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 4 | 2 | 22 |
| 2 | Minoxidil Liniment | 4 | 2 | 52 |
| 3 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 4 | Acetylcysteine Injection | 2 | 2 | 53 |
| 5 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 6 | 甘油磷酸钠注射液 · No verified English name | 2 | 2 | 7 |
| 7 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 8 | 维生素K1滴剂 · No verified English name | 2 | 2 | 3 |
| 9 | Cimetidine Injection | 2 | 2 | 5 |
| 10 | Voriconazole Tablets | 2 | 1 | 1 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Qing Shan Li Kang Pharma Co., Ltd. romanized | 12 | 6 | 12 |
| 2 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 3 | Beijing Min Hai Bio Technology Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 6 | Ningbo Tian Yi Pharma Technology Co., Ltd. romanized | 5 | 5 | 5 |
| 7 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | AstraZeneca AB | 5 | 2 | 0 |
| 9 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 4 | 4 | 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
154 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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.
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.