YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 360 drug applications between 15 April 2026 and 21 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 46 drug names.
2026/04/15 – 2026/04/21
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 94
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
360filings, 57 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 199 |
| New drug | 65 |
| Generic | 57 |
| Import | 16 |
| Unspecified | 12 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 170 |
| TCM | 127 |
| Therapeutic biologic | 52 |
| Biologic | 10 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用磷酸左奥硝唑酯二钠 · No verified English name | 2 | 2 | 22 |
| 2 | 头孢丙烯干混悬剂 · No verified English name | 2 | 1 | 2 |
| 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 1 | 23 |
| 4 | Imipenem and Cilastatin Sodium for Injection | 2 | 1 | 6 |
| 5 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
| 6 | 盐酸氢吗啡酮片 · No verified English name | 2 | 1 | 0 |
| 7 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 8 | Amlodipine Besylate Tablets | 2 | 1 | 8 |
| 9 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 1 | 12 |
| 10 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 1 | 5 |
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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 7 | 3 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Xinjiang Wei Wu Er Pharma Co., Ltd. romanized | 6 | 3 | 0 |
| 4 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Fuzhou Min Hai Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Xian Bo Ai Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Yunnan Bai Yao Group Co., Ltd. romanized | 4 | 3 | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/04/21Import · Class 2.4 | Upadacitinib Sustained-release TabletsJXHS2600042 | AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V. |
| 2026/04/21Import · Class 2.4 | LOU064片 · No verified English nameJXHL2600117 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/04/21Generic · Class 3 | Ketoprofen PatchesCYHS2600915 | Beijing Foyou Pharma CO.,LTD; Fu Yuan Pharma Co., Ltd. romanized |
| 2026/04/21Generic · Class 3 | Ketoprofen PatchesCYHS2600914 | Beijing Foyou Pharma CO.,LTD; Fu Yuan Pharma Co., Ltd. romanized |
| 2026/04/21Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2600911 | San Jin Group Hunan San Jin Pharmaceutical Co., Ltd. romanized |
| 2026/04/21Generic · Class 3 | Progesterone InjectionCYHS2600910 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2026/04/21Generic · Class 3 | Ebastine Oral SolutionCYHS2600909 | Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2026/04/21Generic · Class 3 | 盐酸氢吗啡酮片 · No verified English nameCYHL2600055 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/04/21Generic · Class 3 | 盐酸氢吗啡酮片 · No verified English nameCYHL2600054 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/04/21New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2600428 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/04/21New drug · Class 1 | HMBD-001 · No verified English nameCXSL2600427 | Shanghai He Wei Si Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/21New drug · Class 2.2 | HY-1016缓释注射液 · No verified English nameCXHL2600469 | Name not romanized |
| 2026/04/21New drug · Class 2.2 | HY-1016缓释注射液 · No verified English nameCXHL2600468 | Name not romanized |
| 2026/04/21New drug · Class 2.2 | HY-1016缓释注射液 · No verified English nameCXHL2600467 | Name not romanized |
| 2026/04/21New drug · Class 2.2 | HY-1016缓释注射液 · No verified English nameCXHL2600466 | Name not romanized |
| 2026/04/20New drug · Class 1 | CMS-F021凝胶 · No verified English nameCXHL2600472 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/20New drug · Class 1 | CMS-F021凝胶 · No verified English nameCXHL2600471 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/20New drug · Class 1 | CMS-F021凝胶 · No verified English nameCXHL2600470 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/20New drug · Class 1 | BG-75202片 · No verified English nameCXHL2600465 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/20New drug · Class 1 | BG-75202片 · No verified English nameCXHL2600464 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/20New drug · Class 1 | BG-75202片 · No verified English nameCXHL2600463 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2026/04/18Generic · Class 3 | Methocarbamol InjectionCYHS2600895 | Jiangsu Fu Bang Pharma Co., Ltd. romanized |
| 2026/04/18Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2600894 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2026/04/18Generic · Class 3 | 头孢丙烯干混悬剂 · No verified English nameCYHS2600893 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2026/04/18Generic · Class 3 | Fudosteine oral solutionCYHS2600892 | Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized |
| 2026/04/18New drug · Class 2.2 | HKGM-452 · No verified English nameCXHL2600462 | Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2026/04/18New drug · Class 1 | TT-01488片 · No verified English nameCXHL2600461 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2026/04/18New drug · Class 1 | PP011胶囊 · No verified English nameCXHL2600460 | Pei Tai (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/04/17Import · Class 2.2 | 特立妥单抗注射液 · No verified English nameJXSS2600039 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2026/04/17Import · Class 2.2 | 特立妥单抗注射液 · No verified English nameJXSS2600038 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
69 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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