YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 302 drug applications between 23 July 2025 and 29 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 56 drug names.
2025/07/23 – 2025/07/29
- New acceptances this week
- 302
- Drugs with new generic filings (by drug name, de-duplicated)
- 56
- Accepted this week, now under review
- 69
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
302filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 125 |
| Generic | 75 |
| New drug | 73 |
| Import | 22 |
| Unspecified | 4 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 195 |
| TCM | 62 |
| Therapeutic biologic | 42 |
| Biologic | 2 |
| Prophylactic 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
56 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 2 | Finerenone Tablets | 4 | 2 | 69 |
| 3 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 4 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 5 | Propofol Medium And Long Chain Fat Emulsion Injection | 2 | 1 | 3 |
| 6 | Lidocaine and Prilocaine Cream | 2 | 1 | 24 |
| 7 | Fruquintinib Capsules | 2 | 1 | 4 |
| 8 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 22 |
| 9 | Doxycycline Hyclate for Injection | 2 | 1 | 11 |
| 10 | Safinamide Methansulfonate Tablets | 2 | 1 | 20 |
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
198 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Yunnan Jin Bi Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Eli Lilly and Company | 6 | 1 | 0 |
| 3 | Henan Zhen Shi Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 4 | AbbVie Inc. | 5 | 1 | 0 |
| 5 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Novartis Pharma AG | 3 | 3 | 0 |
| 9 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 3 | 3 | 2 |
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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/07/29New drug · Class 1 | QLS1410片 · No verified English nameCXHL2500782 | Qilu Pharmaceutical Co., Ltd. |
| 2025/07/29New drug · Class 1 | QLS1410片 · No verified English nameCXHL2500781 | Qilu Pharmaceutical Co., Ltd. |
| 2025/07/28Generic · Class 3 | Indobufen TabletsCYHS2502710 | Chengdu Zong Lian Medical Health Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2025/07/28Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2502705 | Qingdao Rui Nai Medical Technology Co., Ltd. romanized |
| 2025/07/28Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2502704 | Qingdao Rui Nai Medical Technology Co., Ltd. romanized |
| 2025/07/28Generic · Class 3 | Potassium Chloride InjectionCYHS2502703 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2025/07/28Generic · Class 3 | 丙氯拉嗪栓 · No verified English nameCYHL2500132 | Hai Hong Heng Long (Hainan) Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 1.2 | HQY总黄酮胶囊 · No verified English nameCXZL2500057 | Nanjing San Tong Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized; Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized; Nanjing Shi Zhong Hospital romanized |
| 2025/07/28New drug · Class 1.2 | HQY总黄酮提取物 · No verified English nameCXZL2500056 | Nanjing San Tong Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized; Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized; Nanjing Shi Zhong Hospital romanized |
| 2025/07/28New drug · Class 1.1 | 糖宁通络片 · No verified English nameCXZL2500055 | Bai Ling Yu Xiu (Zhuhai) Pharmaceuticals Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | IBI354 · No verified English nameCXSL2500632 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | 镥[177Lu]-BL-ARC001注射液 · No verified English nameCXSL2500631 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/07/28New drug · Class 2.2 | LY01015注射液 · No verified English nameCXSL2500630 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 2.2 | LY01015注射液 · No verified English nameCXSL2500629 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | 注射用BA1301 · No verified English nameCXSL2500628 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500627 | Beijing Di Yi Bio Technology Kai Fa Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | MG-K10人源化单抗注射液 · No verified English nameCXSL2500626 | Hunan Mai Ji Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | MG-K10人源化单抗注射液 · No verified English nameCXSL2500625 | Hunan Mai Ji Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 2.2 | 拉莫三嗪干混悬剂 · No verified English nameCXHS2500087 | Shanghai Ao Ke Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/07/28New drug · Class 2.2 | 拉莫三嗪干混悬剂 · No verified English nameCXHS2500086 | Shanghai Ao Ke Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | BGB-53038胶囊 · No verified English nameCXHL2500768 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | BGB-53038胶囊 · No verified English nameCXHL2500767 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2500766 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | BGB-53038胶囊 · No verified English nameCXHL2500765 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | AL28979片 · No verified English nameCXHL2500764 | Nanjing Ai De Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | TQB3217片 · No verified English nameCXHL2500763 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/07/28New drug · Class 1 | TQB3217片 · No verified English nameCXHL2500762 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/07/28New drug · Class 2.3 | HKGM-453 · No verified English nameCXHL2500761 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized |
| 2025/07/25Import · Class 1 | MK-7240注射液 · No verified English nameJXSL2500132 | Merck Sharp & Dahme LLC; Name not romanized |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2500131 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
84 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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