YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 364 drug applications between 19 March 2026 and 25 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 38 drug names.
2026/03/19 – 2026/03/25
- New acceptances this week
- 364
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 75
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
364filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 236 |
| New drug | 55 |
| Generic | 44 |
| Import | 12 |
| Unspecified | 9 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 190 |
| TCM | 139 |
| Therapeutic biologic | 29 |
| Biologic | 5 |
| 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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Levofloxacin Eye Drops | 3 | 1 | 16 |
| 2 | Selexipag Tablets | 2 | 1 | 24 |
| 3 | 培美曲塞二钠注射液 · No verified English name | 2 | 1 | 2 |
| 4 | 头孢地尼颗粒 · No verified English name | 2 | 1 | 3 |
| 5 | Lacidipine Tablets | 2 | 1 | 7 |
| 6 | Ethyl Iosapentate Capsules | 1 | 1 | 27 |
| 7 | 二硫化硒洗剂 · No verified English name | 1 | 1 | 14 |
| 8 | 伏硫西汀滴剂 · No verified English name | 1 | 1 | 1 |
| 9 | 依非米替片(I) · No verified English name | 1 | 1 | 2 |
| 10 | 双氯芬酸钠搽剂 · No verified English name | 1 | 1 | 1 |
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
206 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Yi Chun Kang Er Xin Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 10 | 9 | 0 |
| 3 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 7 | 1 | 0 |
| 7 | Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Nanjing Tong Ren Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/25Import · Class 1 | 注射用precemtabart tocentecan · No verified English nameJXSL2600085 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/03/25New drug · Class 2.4 | 重组人白蛋白注射液 · No verified English nameCXSS2600050 | Tong Hua An Rui Te Biopharmaceutical Co., Ltd. romanized |
| 2026/03/25New drug · Class 1 | TUL321胶囊 · No verified English nameCXHL2600377 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2026/03/25New drug · Class 1 | TUL321胶囊 · No verified English nameCXHL2600376 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2026/03/25New drug · Class 1 | TUL321胶囊 · No verified English nameCXHL2600375 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2026/03/24Generic · Class 3 | 培美曲塞二钠注射液 · No verified English nameCYHS2600712 | Sichuan Shuang Tong Medical Technology Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/03/24Generic · Class 3 | 培美曲塞二钠注射液 · No verified English nameCYHS2600711 | Sichuan Shuang Tong Medical Technology Co., Ltd. romanized; Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/03/24Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2600709 | Beijing SL Pharmaceutical Co., Ltd. |
| 2026/03/24Generic · Class 3 | 双氯芬酸钠搽剂 · No verified English nameCYHS2600704 | Jing Shi (Hangzhou) Pharma Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2026/03/24Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2600703 | Ying Ke Rui (Zhuhai Jin Wan) Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | 注射用BL-M08D1 · No verified English nameCXSL2600348 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | GenSci161注射液 · No verified English nameCXSL2600347 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2600346 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2600345 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | HB0056注射液 · No verified English nameCXSL2600344 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | 治疗用(合成肽)乙型肝炎疫苗 · No verified English nameCXSL2600343 | Nuo He Tai Bio Technology (Chongqing) Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | ODV混悬滴眼液 · No verified English nameCXHL2600366 | Shenzhen Ruo Jian Hui Tong Bio Technology Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | ODV混悬滴眼液 · No verified English nameCXHL2600365 | Shenzhen Ruo Jian Hui Tong Bio Technology Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | ODV混悬滴眼液 · No verified English nameCXHL2600364 | Shenzhen Ruo Jian Hui Tong Bio Technology Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | XNW5004片 · No verified English nameCXHL2600363 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | XNW5004片 · No verified English nameCXHL2600362 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | ANS014004片 · No verified English nameCXHL2600358 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2026/03/24New drug · Class 1 | ANS014004片 · No verified English nameCXHL2600357 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2026/03/23Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600090 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600089 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Import · Class 2.4 | 那米司特片 · No verified English nameJXHL2600088 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2026/03/23Generic · Class 3 | 头孢克肟干混悬剂 · No verified English nameCYHS2600697 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized |
| 2026/03/23Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2600696 | Suzhou Hong Sen Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂 · No verified English nameCXHL2600361 | Jiangsu De Mai Pharma Co., Ltd. romanized |
| 2026/03/23New drug · Class 2.2 | DMI019鼻喷雾剂 · No verified English nameCXHL2600360 | Jiangsu De Mai Pharma Co., Ltd. romanized |
50 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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