YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 659 drug applications between 7 May 2026 and 13 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 66 drug names.
2026/05/07 – 2026/05/13
- New acceptances this week
- 659
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 161
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
659filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 373 |
| New drug | 110 |
| Generic | 92 |
| Import | 53 |
| Unspecified | 21 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 311 |
| TCM | 229 |
| Therapeutic biologic | 99 |
| Biologic | 17 |
| Prophylactic 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
66 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dotinurad Tablets | 4 | 2 | 55 |
| 2 | Galanthamine Hydrobromide Oral Solution | 3 | 1 | 5 |
| 3 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 4 | Edaravone and Dexborneol Concentrated Solution for Injection | 2 | 2 | 34 |
| 5 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 7 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 2 | 12 |
| 8 | Lidocaine and Tetracaine Cream | 2 | 1 | 2 |
| 9 | Piracetam Injection | 2 | 1 | 9 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
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
365 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 23 | 20 | 0 |
| 2 | AstraZeneca AB | 21 | 3 | 0 |
| 3 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 12 | 8 | 0 |
| 4 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company | 8 | 2 | 0 |
| 5 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Pfizer Inc. | 6 | 5 | 0 |
| 7 | Eli Lilly and Company | 6 | 3 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 10 | Novo Nordisk A/S | 5 | 5 | 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
187 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/13Import · Class 2.2 | 萨特利珠单抗注射液 · No verified English nameJXSS2600042 | Roche Pharma (Schweiz) AG; Utsunomiya Plant of Chugai Pharma Manufacturing Co. Ltd.; Roche (China) Holding Ltd. |
| 2026/05/13Import · Class 1 | Seltorexant薄膜包衣片 · No verified English nameJXHL2600175 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/05/13Import · Class 2.2; 2.4 | BMS-986519肠溶胶囊 · No verified English nameJXHL2600174 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 2.2; 2.4 | BMS-986519肠溶胶囊 · No verified English nameJXHL2600173 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 2.2; 2.4 | BMS-986519肠溶胶囊 · No verified English nameJXHL2600172 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 2.2; 2.4 | BMS-986519肠溶胶囊 · No verified English nameJXHL2600171 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 1 | FOG-001注射液 · No verified English nameJXHL2600170 | Parabilis Medicines Inc.; Parabilis Medicines (Shanghai) Ltd. Co |
| 2026/05/13Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2600169 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2600168 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2600167 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2600166 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/05/13Import · Class 1 | Olomorasib胶囊 · No verified English nameJXHL2600165 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/05/13Import · Class 1 | Olomorasib胶囊 · No verified English nameJXHL2600164 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/05/13Generic · Class 3 | Sodium Lactate Ringer's Irrigation SolutionCYHS2601118 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2026/05/13Generic · Class 3 | Amisulpride InjectionCYHS2601115 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2026/05/13Generic · Class 3 | 比拉斯汀口崩片 · No verified English nameCYHS2601114 | Zhejiang Kang De Pharma Group Co., Ltd. romanized |
| 2026/05/13Generic · Class 3 | Ibuprofen InjectionCYHS2601110 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2026/05/13Generic · Class 3 | Ibuprofen InjectionCYHS2601109 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2026/05/13Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2601108 | Zhejiang Di Er Pharma Co., Ltd. romanized |
| 2026/05/13Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2601107 | Zhejiang Di Er Pharma Co., Ltd. romanized |
| 2026/05/13Generic · Class 3 | Epalrestat TabletsCYHS2601105 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized |
| 2026/05/13New drug · Class 1.1 | 柴芪固溺丸 · No verified English nameCXZL2600043 | Shanghai Shou Zheng Zhong Pharmaceuticals Research Co., Ltd. romanized |
| 2026/05/13New drug · Class 1 | 注射用IMD1828 · No verified English nameCXSL2600517 | Shanghai Ying Mai De Medical Technology Co., Ltd. romanized |
| 2026/05/13New drug · Class 1 | 注射用SHR-A2009 · No verified English nameCXSL2600515 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/13New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600514 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/05/13New drug · Class 1 | IBR900细胞注射液 · No verified English nameCXSL2600513 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/13New drug · Class 1 | IBR900细胞注射液 · No verified English nameCXSL2600512 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/13New drug · Class 1 | IBR900细胞注射液 · No verified English nameCXSL2600511 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/13New drug · Class 1 | IBR900细胞注射液 · No verified English nameCXSL2600510 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/13New drug · Class 1 | IBR900细胞注射液 · No verified English nameCXSL2600509 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
157 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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