YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 317 drug applications between 20 April 2025 and 26 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 65 drug names.
2025/04/20 – 2025/04/26
- New acceptances this week
- 317
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 34
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
317filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 157 |
| Generic | 82 |
| New drug | 36 |
| Import | 30 |
| Unspecified | 8 |
| Import re-registration | 3 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 51 |
| Therapeutic biologic | 25 |
| 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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pemafibrate Tablets | 4 | 4 | 23 |
| 2 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
| 3 | 草酸艾司西酞普兰口服溶液 · No verified English name | 2 | 2 | 11 |
| 4 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 5 | Dimethyl Fumarate Delayed-release Capsules | 2 | 1 | 0 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 8 | Levobupivacaine Hydrochloride Injection | 2 | 1 | 2 |
| 9 | Propranolol Hydrochloride Injection | 2 | 1 | 4 |
| 10 | Fudosteine oral solution | 2 | 1 | 7 |
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
186 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 16 | 10 | 0 |
| 2 | Eli Lilly and Company | 14 | 2 | 0 |
| 3 | Dan Dong Hong Ye Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 3 |
| 7 | Shanxi Jin Xin Shuang He Pharma Co., Ltd. romanized | 4 | 4 | 1 |
| 8 | Rong Kang Group Guangxi Kang Shi Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | M/s Cipla Ltd. | 4 | 3 | 0 |
| 10 | Janssen-Cilag International NV | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/26Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2501583 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/04/26Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2501582 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2025/04/26Generic · Class 3 | 甲氧氯普胺片 · No verified English nameCYHS2501580 | Hua Nuo Pharmaceuticals (Guangzhou) Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2025/04/26New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500037 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/04/26New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2500036 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/04/26New drug · Class 2.2 | ACIERT缓释片 · No verified English nameCXHL2500412 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2025/04/26New drug · Class 2.2 | ACIERT缓释片 · No verified English nameCXHL2500411 | Jilin Tian Heng Pharma Co., Ltd. romanized |
| 2025/04/25Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSL2500064 | Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2025/04/25Import · Class 2.4 | 匹妥布替尼片 · No verified English nameJXHL2500102 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/25Import · Class 2.4 | 匹妥布替尼片 · No verified English nameJXHL2500101 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/25Import · Class 1 | BPC2001注射液 · No verified English nameJXHL2500100 | BioPhoenix Co. Ltd.; WuXi Clinical Development Services (Shanghai) Co. Ltd. |
| 2025/04/25Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2501576 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/04/25Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2501574 | Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized |
| 2025/04/25Generic · Class 3 | Luliconazole CreamCYHS2501571 | Hubei Cheng Tian Pharma Co., Ltd. romanized |
| 2025/04/25Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2501570 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/04/25Generic · Class 3 | Ferrous Succinate TabletsCYHS2501562 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2025/04/25Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2501560 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/04/25Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2501557 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2025/04/25Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2501556 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/25Generic · Class 3 | Fudosteine oral solutionCYHS2501555 | Hunan Yi Ge Pharmaceutical Co., Ltd. romanized |
| 2025/04/25Generic · Class 3 | Fudosteine oral solutionCYHS2501554 | Hunan Yi Ge Pharmaceutical Co., Ltd. romanized |
| 2025/04/25New drug · Class 1.1 | 化瘀解热颗粒 · No verified English nameCXZL2500025 | Sichuan Sheng Zhong Pharmaceuticals Zhuan Hua Yi Xue Center romanized |
| 2025/04/25New drug · Class 1 | HSK21542注射液 · No verified English nameCXHL2500410 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized |
| 2025/04/25New drug · Class 2.2 | 石杉碱甲口服溶液 · No verified English nameCXHL2500409 | Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2025/04/25New drug · Class 2.2 | BCM1129 · No verified English nameCXHL2500408 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500099 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500098 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500097 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500096 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/04/24Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500095 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
60 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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