YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 289 drug applications between 22 May 2025 and 28 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 53 drug names.
2025/05/22 – 2025/05/28
- New acceptances this week
- 289
- Drugs with new generic filings (by drug name, de-duplicated)
- 53
- Accepted this week, now under review
- 43
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, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 144 |
| Generic | 74 |
| New drug | 48 |
| Import | 11 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 46 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 7 |
| Biologic | 3 |
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
53 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 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 3 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 4 | Potassium Chloride Oral Solution | 3 | 1 | 11 |
| 5 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 6 | Iguratimod Tablets | 2 | 2 | 23 |
| 7 | Aspirin Enteric-coated Tablets | 2 | 2 | 10 |
| 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 | Levothyroxine Sodium Tablets | 2 | 1 | 12 |
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
179 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 9 | 9 | 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 | Jilin Sheng Qi Ke Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Guizhou Sheng Shi Long Fang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | AstraZeneca AB | 4 | 2 | 0 |
| 9 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 4 | 2 | 2 |
| 10 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/28Import · Class 2.2 | 注射用维泊妥珠单抗 · No verified English nameJXSS2500069 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2025/05/28Import · Class 2.2 | 注射用维泊妥珠单抗 · No verified English nameJXSS2500068 | Roche Pharma (Schweiz) AG; BSP Pharmaceuticals S.p.A.; Roche (China) Holding Ltd. |
| 2025/05/28Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2500067 | UCB Pharma S.A.; Vetter Pharma- Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd |
| 2025/05/28Import · Class 3.1 | 比奇珠单抗注射液 · No verified English nameJXSS2500066 | UCB Pharma S.A.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd |
| 2025/05/28Generic · Class 3 | Amisulpride Oral SolutionCYHS2501908 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | 注射用盐酸头孢替安/氯化钠注射液 · No verified English nameCYHS2501904 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2501901 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2501900 | Nanjing Hai Jing Pharma Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2501895 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/05/28Generic · Class 3 | Cabergoline TabletsCYHL2500098 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/05/28New drug · Class 2.2 | 三价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2500428 | Lanzhou Bai Ling Bio Technology Co., Ltd. romanized; Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized |
| 2025/05/28New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2500427 | Le Pu Jian Tang Pharma (Chongqing) Co., Ltd. romanized |
| 2025/05/28New drug · Class 1 | HEC-301注射液 · No verified English nameCXSL2500426 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized; Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Shenzhen Shi Ge Bi Jia Fen Zi Drug Innovation Center Co., Ltd. romanized |
| 2025/05/28New drug · Class 1 | 洛布替尼片 · No verified English nameCXHS2500057 | Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2025/05/28New drug · Class 1 | 洛布替尼片 · No verified English nameCXHS2500056 | Guangzhou Lu Peng Pharmaceutical Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2025/05/28New drug · Class 2.2; 2.4 | MZ-01吸入溶液 · No verified English nameCXHL2500513 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/28New drug · Class 1 | 富马酸奥比特嗪肠溶微丸胶囊 · No verified English nameCXHL2500512 | Shenzhen Shi Zhen Xing Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/28New drug · Class 1 | SYN818片 · No verified English nameCXHL2500511 | Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/28New drug · Class 1 | SYN818片 · No verified English nameCXHL2500510 | Hangzhou Sheng Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 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 |
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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