YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 419 drug applications between 19 June 2026 and 25 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 31 drug names.
2026/06/19 – 2026/06/25
- New acceptances this week
- 419
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- Accepted this week, now under review
- 106
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
419filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 300 |
| New drug | 47 |
| Generic | 43 |
| Import | 15 |
| Unspecified | 11 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 190 |
| Chemical drug | 153 |
| Therapeutic biologic | 70 |
| Biologic | 4 |
| 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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nafamostat Mesilate for Injection | 7 | 4 | 38 |
| 2 | Fosfomycin Sodium For Injection | 3 | 1 | 16 |
| 3 | Methylprednisolone Sodium Succinate for injection | 2 | 1 | 12 |
| 4 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
| 5 | Minoxidil Liniment | 2 | 1 | 52 |
| 6 | 马来酸左氨氯地平片 · No verified English name | 2 | 1 | 3 |
| 7 | 1.5 mmol/L钙碳酸氢钠血滤置换液 · No verified English name | 1 | 1 | 1 |
| 8 | Upadacitinib Sustained-release Tablets | 1 | 1 | 43 |
| 9 | Acetylcysteine Tablets | 1 | 1 | 8 |
| 10 | Edaravone and Dexborneol Concentrated Solution for Injection | 1 | 1 | 34 |
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
245 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Mu Dan Jiang Ling Tai Pharma Co., Ltd. romanized | 17 | 16 | 0 |
| 2 | Dong E E Jiao Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Guizhou Yi Bai Nv Zi Da Pharmaceutical Factory Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Novo Nordisk A/S | 7 | 2 | 0 |
| 6 | AstraZeneca AB | 6 | 5 | 0 |
| 7 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Janssen-Cilag International NV | 5 | 3 | 0 |
| 10 | Shi Ze Bio Pharma (Shanghai) Co., Ltd. romanized | 5 | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/25Import · Class 3.1 | 莱达西贝普注射液 · No verified English nameJXSS2600054 | LIB Therapeutics Inc.; PCI San Diego Inc.; Everest Medicines (China) Co. Ltd. |
| 2026/06/25Import · Class 2.2 | DS-1062a · No verified English nameJXSL2600150 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
| 2026/06/25Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2600226 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/06/25Import · Class 2.4 | 甲苯磺酸利特昔替尼胶囊 · No verified English nameJXHL2600225 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/06/25Generic · Class 3 | 碳酸氢钠血滤置换液(钾2mmol/L无钙) · No verified English nameCYHS2601500 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2026/06/25Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601499 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2026/06/25Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2601497 | Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized |
| 2026/06/25Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601495 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanized |
| 2026/06/25Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601494 | Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Zhejiang Ya Tai Pharma Co., Ltd. romanized |
| 2026/06/25Generic · Class 3 | 1.5 mmol/L钙碳酸氢钠血滤置换液 · No verified English nameCYHS2601492 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2026/06/25New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSS2600102 | Qilu Pharmaceutical Co., Ltd. |
| 2026/06/25New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSS2600101 | Qilu Pharmaceutical Co., Ltd. |
| 2026/06/25New drug · Class 1 | EP-0210单抗注射液 · No verified English nameCXSL2600677 | Chengdu You Luo Bio Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | 注射用BL-M09D1 · No verified English nameCXSL2600676 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | 注射用YL217 · No verified English nameCXSL2600675 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | BXP-001注射液 · No verified English nameCXSL2600674 | Shenzhen Bei Wan Bio Technology Co., Ltd. romanized; Ge Yuan Zhi Shan (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | META 10-19注射液 · No verified English nameCXSL2600673 | Shenzhen Lai Mang Bio Technology Co., Ltd. romanized; Hangzhou Lai Mang Bio Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | META 10-19注射液 · No verified English nameCXSL2600672 | Shenzhen Lai Mang Bio Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | META 10-19注射液 · No verified English nameCXSL2600671 | Shenzhen Lai Mang Bio Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 2.2 | TH5112 · No verified English nameCXHL2600761 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | WD-890片 · No verified English nameCXHL2600760 | Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | DX1002片 · No verified English nameCXHL2600759 | Guangzhou An Hao Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | 注射用QHL-1231 · No verified English nameCXHL2600758 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | SA030注射液 · No verified English nameCXHL2600757 | Suzhou Shi An Bio Technology Co., Ltd. romanized; Hangzhou Shi An Yuan Tai Bio Technology Co., Ltd. romanized; Shi An Yuan Tai (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | HRS-4139片 · No verified English nameCXHL2600756 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | HRS-4139片 · No verified English nameCXHL2600755 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/25New drug · Class 1 | HRS-4139片 · No verified English nameCXHL2600754 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Beijing Tuo Jie Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/06/24Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2601486 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2026/06/24Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2601485 | Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2026/06/24Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2601484 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
51 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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