YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 300 drug applications between 21 July 2025 and 27 July 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 62 drug names.
2025/07/21 – 2025/07/27
- New acceptances this week
- 300
- Drugs with new generic filings (by drug name, de-duplicated)
- 62
- Accepted this week, now under review
- 70
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
300filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| Generic | 84 |
| New drug | 56 |
| Import | 24 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| TCM | 51 |
| Therapeutic biologic | 38 |
| Prophylactic biologic | 4 |
| 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
62 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 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 3 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 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 | Doxofylline Tablets | 2 | 1 | 2 |
| 10 | Doxycycline Hyclate for Injection | 2 | 1 | 11 |
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
199 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 | AbbVie Inc. | 6 | 1 | 0 |
| 3 | Eli Lilly and Company | 6 | 1 | 0 |
| 4 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 2 | 2 |
| 5 | Henan Zhen Shi Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Guangdong Xiang Shan Tang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 7 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 8 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Hai Pai Tai Ke (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2500130 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2500129 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2500128 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/07/25Import · Class 2.2 | Risankizumab注射液 · No verified English nameJXSL2500127 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/07/25Generic · Class 3 | Perospirone Hydrochloride TabletsCYHS2502697 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/07/25Generic · Class 3 | Perospirone Hydrochloride TabletsCYHS2502696 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/07/25Generic · Class 3 | 注射用盐酸头孢替安/氯化钠注射液 · No verified English nameCYHS2502693 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/07/25New drug · Class 3.1 | 芍药甘草颗粒 · No verified English nameCXZS2500031 | Guo Yao Group Guangdong Huan Qiu Pharmaceutical Co., Ltd. romanized |
| 2025/07/25New drug · Class 2.3 | 欣力康胶囊 · No verified English nameCXZL2500054 | Guiyang Xin Tian Pharma Co., Ltd. romanized |
| 2025/07/25New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSS2500077 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized |
| 2025/07/25New drug · Class 2.2 | 贝莫苏拜单抗注射液 · No verified English nameCXSL2500624 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/07/25New drug · Class 1 | 注射用JS107 · No verified English nameCXSL2500623 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/25New drug · Class 1 | 注射用HDM2017 · No verified English nameCXSL2500622 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/07/25New drug · Class 1 | 注射用JS207 · No verified English nameCXSL2500621 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/25New drug · Class 1 | 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2500620 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/25New drug · Class 1 | 注射用HLX43 · No verified English nameCXSL2500619 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/25New drug · Class 3.3 | 罗莫佐单抗注射液 · No verified English nameCXSL2500618 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized |
| 2025/07/25New drug · Class 1 | 注射用JS207 · No verified English nameCXSL2500617 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/07/25New drug · Class 3.3 | 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2500616 | Beijing Bai Hui Bio Technology Co., Ltd. romanized; Bo Hui Biopharmaceutical Co., Ltd. romanized |
| 2025/07/25New drug · Class 1 | 注射用GD-11 · No verified English nameCXHS2500085 | Jiangsu Vanguard Pharmaceutical Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/07/25New drug · Class 2.4 | 注射用紫杉醇阳离子脂质体 · No verified English nameCXHL2500760 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2025/07/25New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2500759 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/07/25New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2500758 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/07/25New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2500757 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/07/25New drug · Class 1 | WJB001胶囊 · No verified English nameCXHL2500756 | Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/07/24Import · Class 2.1 | ASP5541注射液 · No verified English nameJXHL2500200 | Astellas Pharma Global Development Inc.; Astellas (China) Investment Co. Ltd. |
| 2025/07/24Generic · Class 3 | 盐酸丙卡特罗干糖浆 · No verified English nameCYHS2502690 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/07/24Generic · Class 3 | Ebastine Oral SolutionCYHS2502684 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
72 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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