YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 289 drug applications between 21 May 2025 and 27 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.
2025/05/21 – 2025/05/27
- New acceptances this week
- 289
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 40
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
289filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 148 |
| Generic | 65 |
| New drug | 55 |
| Import | 10 |
| Unspecified | 7 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| Therapeutic biologic | 51 |
| TCM | 49 |
| Prophylactic biologic | 6 |
| 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Adapalene And Benzoyl Peroxide Gel | 6 | 3 | 30 |
| 2 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 3 | Potassium Chloride Oral Solution | 3 | 1 | 11 |
| 4 | 维立西呱片 · No verified English name | 3 | 1 | 8 |
| 5 | Iguratimod Tablets | 2 | 2 | 23 |
| 6 | Aspirin Enteric-coated Tablets | 2 | 2 | 10 |
| 7 | 丙戊酸钠缓释微片 · No verified English name | 2 | 1 | 0 |
| 8 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 9 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 10 | Dapagliflozin Tablets | 2 | 1 | 84 |
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
181 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Guangdong Sunho Pharmaceutical Co., Ltd. | 6 | 3 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Zhong Mei Shanghai Shi Gui Bao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | AstraZeneca AB | 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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/27Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2500065 | UCB Pharma S.A.; Vetter Pharma- Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd |
| 2025/05/27Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2500064 | UCB Pharma S.A.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd |
| 2025/05/27Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2501884 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/05/27Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2501883 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/05/27Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂(II) · No verified English nameCYHS2501882 | Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/05/27Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2501876 | Hunan Run Xing Pharma Co., Ltd. romanized; Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized |
| 2025/05/27Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2501874 | Jinan Zhong Yu Run Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2025/05/27New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSS2500054 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized; Beijing Hua Fang Tian Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/05/27New drug · Class 1 | 重组人PD-L1/CD3 双抗溶瘤II型单纯疱疹病毒注射液(Vero细胞) · No verified English nameCXSL2500425 | Wuhan Bin Hui Bio Technology Co., Ltd. romanized |
| 2025/05/27New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500424 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2025/05/27New drug · Class 1 | 注射用RMMV疫苗 · No verified English nameCXSL2500423 | Changchun Kang Yue Bio Technology Co., Ltd. romanized |
| 2025/05/27New drug · Class 1 | 注射用IMD303 · No verified English nameCXSL2500422 | Qin He Li (Chengdu) Pharma Co., Ltd. romanized |
| 2025/05/24Import · Class 1 | 注射用Felzartamab · No verified English nameJXSL2500082 | Biogen Idec Research Limited |
| 2025/05/24New drug · Class 2.2 | 瑞基奥仑赛注射液 · No verified English nameCXSS2500053 | Shanghai Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized; Suzhou Yao Ming Ju Nuo Bio Technology Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | IBI363 · No verified English nameCXSL2500421 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | IBI363 · No verified English nameCXSL2500420 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | SSGJ-706注射液 · No verified English nameCXSL2500419 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | SSGJ-706注射液 · No verified English nameCXSL2500418 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | VB19055片 · No verified English nameCXHL2500509 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | VB19055片 · No verified English nameCXHL2500508 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | VB19055片 · No verified English nameCXHL2500507 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/24New drug · Class 1 | VB19055片 · No verified English nameCXHL2500506 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/24New drug · Class 2.2 | HKG-456 · No verified English nameCXHL2500505 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/23Import · Class 1 | GHZ339注射液 · No verified English nameJXSL2500081 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/05/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2501864 | Hangzhou He Kang Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2501863 | Hangzhou He Kang Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2501862 | Hangzhou He Kang Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Hydrotalcite SuspensionCYHS2501860 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2501853 | Hubei Tian Sheng Pharma Co., Ltd. romanized |
| 2025/05/23Generic · Class 3 | Potassium Phosphates InjectionCYHS2501851 | Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized |
57 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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