YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 272 drug applications between 21 February 2025 and 27 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 57 drug names.
2025/02/21 – 2025/02/27
- New acceptances this week
- 272
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- Accepted this week, now under review
- 5
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
272filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 141 |
| Generic | 70 |
| New drug | 31 |
| Import | 19 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 41 |
| Therapeutic biologic | 33 |
| Prophylactic biologic | 6 |
| Biologic | 3 |
| In vitro diagnostic reagent | 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
57 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 2 | Bromhexine Hydrochloride Injection | 2 | 2 | 8 |
| 3 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 4 | 多种油脂肪乳注射液(C?~??) · No verified English nameThe source text contains a character that cannot be displayed. | 2 | 1 | 0 |
| 5 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 6 | Nafamostat Mesilate for Injection | 2 | 1 | 38 |
| 7 | Lysine Acetylsalicylate For Injection | 2 | 1 | 8 |
| 8 | 环硅酸锆钠散 · No verified English name | 2 | 1 | 12 |
| 9 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 10 | Isoprenaline Hydrochloride Injection | 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
171 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 16 | 9 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 3 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Boehringer Ingelheim International GmbH | 5 | 4 | 0 |
| 6 | AstraZeneca AB | 4 | 2 | 0 |
| 7 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 8 | Baxter Holding B.V. | 3 | 3 | 0 |
| 9 | TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 3 | 3 | 1 |
| 10 | Sanofi B.V. | 3 | 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
78 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/27Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2500028 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/02/27Import · Class 1 | 瑞米布替尼片 · No verified English nameJXHS2500034 | Novartis Pharma Schweiz AG; Novartis Pharmaceutical Manufacturing LLC; Beijing Novartis Pharma Co. Ltd. |
| 2025/02/27Generic · Class 3 | Calcium Acetate Oral SolutionCYHS2500871 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | Mannitol-S InjectionCYHS2500870 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2500869 | Hainan Mei Kang Da Pharma Co., Ltd. romanized; Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2500868 | Hainan Mei Kang Da Pharma Co., Ltd. romanized; Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2500867 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | Lysine Acetylsalicylate For InjectionCYHS2500866 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | 比拉斯汀口崩片 · No verified English nameCYHS2500863 | Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2500860 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2500854 | Shandong Hua Yao Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2025/02/27Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2500052 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2025/02/27New drug · Class 1 | 注射用YL217 · No verified English nameCXSL2500182 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/27New drug · Class 1.2 | 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2500181 | Ai Mei Innovation Zhe Biopharmaceuticals Research (Shanghai) Co., Ltd. romanized; Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized |
| 2025/02/27New drug · Class 1.4 | 冻干二价重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2500180 | Guangzhou Sui He Bio Technology Co., Ltd. romanized |
| 2025/02/27New drug · Class 1 | SH009注射液 · No verified English nameCXSL2500179 | Nanjing Sheng He Pharma Co., Ltd. romanized |
| 2025/02/26Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2500852 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2025/02/26Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2500847 | YaoPharma Co., Ltd. |
| 2025/02/26Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2500846 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2025/02/26Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2500845 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2025/02/26New drug · Class 1 | FG-B901注射液 · No verified English nameCXSL2500178 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2025/02/26New drug · Class 1 | FG-M108注射液 · No verified English nameCXSL2500177 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2025/02/26New drug · Class 1.2 | 冻干鼻喷流感减毒活疫苗 · No verified English nameCXSL2500176 | Di Fu Run Si (Hefei) Bio Technology Co., Ltd. romanized; Zhejiang Di Fu Run Si Bio Technology Co., Ltd. romanized |
| 2025/02/26New drug · Class 1 | 注射用HDM2005 · No verified English nameCXSL2500175 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/02/26New drug · Class 1 | CPD704吸入混悬液 · No verified English nameCXHL2500222 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2025/02/26New drug · Class 2.2 | BCM995 · No verified English nameCXHL2500221 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2025/02/26New drug · Class 2.2 | HKGM-333 · No verified English nameCXHL2500220 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/26New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2500219 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/02/26New drug · Class 1 | BGB-45035片 · No verified English nameCXHL2500218 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/02/25Import · Class 2.2 | 特泽利尤单抗注射液 · No verified English nameJXSS2500020 | AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd. |
48 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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