YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 446 drug applications between 14 July 2026 and 20 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 49 drug names.
2026/07/14 – 2026/07/20
- New acceptances this week
- 446
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 152
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
446filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 280 |
| Generic | 70 |
| New drug | 58 |
| Import | 20 |
| Unspecified | 12 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 221 |
| TCM | 145 |
| Therapeutic biologic | 69 |
| Prophylactic biologic | 8 |
| Biologic | 3 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Baricitinib Tablets | 4 | 2 | 32 |
| 2 | Dotinurad Tablets | 3 | 1 | 55 |
| 3 | Brivaracetam Tablets | 3 | 1 | 19 |
| 4 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 5 | Buprenorphine Transdermal Patches | 2 | 1 | 6 |
| 6 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 7 | Gatifloxacin Eye Drops | 2 | 1 | 3 |
| 8 | Oxaliplatin Injection | 2 | 1 | 4 |
| 9 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 10 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
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
270 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Ji Er Ji Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | An Kang Zheng Da Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | Pfizer Inc. | 6 | 2 | 0 |
| 5 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 6 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Novo Nordisk A/S | 5 | 2 | 0 |
| 8 | Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Shenzhen Shi Yi Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized | 5 | 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
105 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/07/20Import · Class 3.1 | 伊匹木单抗注射液 · No verified English nameJXSS2600063 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Samsung Biologics Co. Ltd; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/07/20Import · Class 1 | AZD5335 · No verified English nameJXSL2600172 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/07/20Import · Class 2.4 | 贝组替凡片 · No verified English nameJXHL2600279 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2026/07/20Import · Class 2.4 | 塞伐艾替尼片 · No verified English nameJXHL2600278 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/07/20Import · Class 2.4 | 塞伐艾替尼片 · No verified English nameJXHL2600277 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2026/07/20Generic · Class 3 | Esketamine Hydrochloride InjectionCYHS2601737 | Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized |
| 2026/07/20Generic · Class 3 | 布美他尼片 · No verified English nameCYHS2601736 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2026/07/20Generic · Class 3 | Potassium Chloride InjectionCYHS2601732 | Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Xian Li Jun Kang Le Pharmaceutical Co., Ltd. romanized |
| 2026/07/20Generic · Class 3 | 盐酸奥洛他定口崩片 · No verified English nameCYHS2601723 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2026/07/20Generic · Class 3 | Dipyridamole TabletsCYHS2601722 | Chengdu Gui He Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | 注射用CS5007 · No verified English nameCXSL2600752 | Ji Shi Pharma (Suzhou) Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | EB070注射液 · No verified English nameCXSL2600751 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | EB070注射液 · No verified English nameCXSL2600750 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | EB070注射液 · No verified English nameCXSL2600749 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2026/07/20New drug · Class 1.2 | 冻干重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2600748 | Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized; Xiamen University romanized |
| 2026/07/20New drug · Class 1 | SHR-3201注射液 · No verified English nameCXSL2600746 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | VCT220片 · No verified English nameCXHS2600104 | Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | VCT220片 · No verified English nameCXHS2600103 | Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2026/07/20New drug · Class 2.2 | N02 · No verified English nameCXHL2600879 | Beijing Bo En Te Pharma Co., Ltd. romanized |
| 2026/07/20New drug · Class 2.2 | N02 · No verified English nameCXHL2600878 | Beijing Bo En Te Pharma Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | VCT220片 · No verified English nameCXHL2600877 | Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | VCT220片 · No verified English nameCXHL2600876 | Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | VCT220片 · No verified English nameCXHL2600875 | Chengdu Wen Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/20New drug · Class 2.4 | HS-10561胶囊 · No verified English nameCXHL2600874 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | BAY 3713372 片 · No verified English nameCXHL2600873 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/07/20New drug · Class 1 | BAY 3713372 片 · No verified English nameCXHL2600872 | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized |
| 2026/07/18Generic · Class 3 | 枸橼酸铁片 · No verified English nameCYHS2601721 | Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2026/07/18New drug · Class 1 | 注射用依康坦博妥塔单抗 · No verified English nameCXSS2600109 | Shanghai Yi Lian Biopharmaceuticals Co., Ltd. romanized; Name not romanized |
| 2026/07/18New drug · Class 2.4 | 瑞维鲁胺片 · No verified English nameCXHL2600871 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/07/18New drug · Class 1 | 注射用JZ1108i聚合物胶束 · No verified English nameCXHL2600870 | Name not romanized |
75 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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