YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 513 drug applications between 10 May 2026 and 16 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 97, covering 63 drug names.
2026/05/10 – 2026/05/16
- New acceptances this week
- 513
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 146
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
513filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 285 |
| Generic | 97 |
| New drug | 93 |
| Import | 19 |
| Import re-registration | 11 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 270 |
| TCM | 168 |
| Therapeutic biologic | 65 |
| Biologic | 8 |
| Prophylactic biologic | 2 |
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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 2 | 70 |
| 2 | Edaravone and Dexborneol Concentrated Solution for Injection | 3 | 3 | 34 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Galanthamine Hydrobromide Oral Solution | 3 | 1 | 5 |
| 5 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 6 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 7 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 8 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 9 | Iomeprol Injection | 2 | 2 | 5 |
| 10 | 二甲硅油乳剂 · No verified English name | 2 | 1 | 14 |
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
283 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 26 | 10 | 0 |
| 2 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 14 | 12 | 0 |
| 3 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company | 8 | 2 | 0 |
| 4 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bao Tou Zhong Yao Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Kyowa Kirin Co. Ltd. | 6 | 1 | 0 |
| 7 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Henan Bai Nian Kang Xin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized | 5 | 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
144 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/15Import · Class 1 | Galvokimig注射液 · No verified English nameJXSL2600116 | UCB Biopharma SRL; UCB Trading (Shanghai) Co. Ltd |
| 2026/05/15New drug · Class 2.3 | 障眼明片 · No verified English nameCXZL2600045 | Guangzhou Bai Yun Shan Zhong Yi Pharma Co., Ltd. romanized |
| 2026/05/15New drug · Class 1 | 注射用QLC5513 · No verified English nameCXSL2600531 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/14Import · Class 1 | VAY736注射液 · No verified English nameJXSL2600115 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/14Import · Class 1 | Enpatoran · No verified English nameJXHL2600178 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2026/05/14Import · Class 1 | LYT-100 (Deupirfenidone) · No verified English nameJXHL2600177 | PureTech LYT 100 Inc. a subsidiary of PureTech Health LLC; IQVIA RDS (Shanghai) Co. Ltd. |
| 2026/05/14Import · Class 2.4 | LNP023胶囊 · No verified English nameJXHL2600176 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/14Generic · Class 3 | Bempedoic Acid TabletsCYHS2601153 | Gan Li Pharma Shandong Co., Ltd. romanized |
| 2026/05/14Generic · Class 3 | 盐酸二甲双胍缓释片(Ⅳ) · No verified English nameCYHS2601148 | De Zhou Bo Cheng Pharmaceutical Co., Ltd. romanized |
| 2026/05/14Generic · Class 3 | 盐酸精氨酸注射液 · No verified English nameCYHS2601144 | Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2026/05/14Generic · Class 3 | 硝酸咪康唑散 · No verified English nameCYHS2601141 | Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2026/05/14Generic · Class 3 | 硝酸咪康唑散 · No verified English nameCYHS2601140 | Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2026/05/14Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHS2601136 | Jiangsu En Hua Pharma Co., Ltd. romanized; Jiangsu En Hua Sai De Pharma Co., Ltd. romanized |
| 2026/05/14Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHS2601135 | Jiangsu En Hua Pharma Co., Ltd. romanized; Jiangsu En Hua Sai De Pharma Co., Ltd. romanized |
| 2026/05/14Generic · Class 3 | LevomilnacipranHydrochloride Extended-release CapsulesCYHS2601134 | Jiangsu En Hua Pharma Co., Ltd. romanized; Jiangsu En Hua Sai De Pharma Co., Ltd. romanized |
| 2026/05/14Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2601132 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2026/05/14Generic · Class 3 | 右美沙芬安非他酮缓释片 · No verified English nameCYHS2601125 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2026/05/14New drug · Class 2.3 | 参芪温阳阴道膨胀栓 · No verified English nameCXZL2600044 | Haerbin Tian Mei Pharma Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | WGc-043注射液 · No verified English nameCXSL2600530 | Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/14New drug · Class 2.2 | 重组B群脑膜炎球菌疫苗(大肠杆菌) · No verified English nameCXSL2600529 | Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized |
| 2026/05/14New drug · Class 2.2 | QL2107注射液 · No verified English nameCXSL2600528 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/14New drug · Class 3.2 | 人血管性血友病因子复合物 · No verified English nameCXSL2600527 | Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | ZM-02眼用注射液 · No verified English nameCXSL2600526 | Zhong Mou Medical Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | 注射用SKB500 · No verified English nameCXSL2600525 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | SYS6043 · No verified English nameCXSL2600524 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | SYS6090注射液 · No verified English nameCXSL2600523 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | 个性化树突状细胞注射液 · No verified English nameCXSL2600522 | Zhong Sheng Kang Yuan Bio Technology (Beijing) Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | SCTB35注射液 · No verified English nameCXSL2600521 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | SCTB35注射液 · No verified English nameCXSL2600520 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2026/05/14New drug · Class 1 | SCTB35注射液 · No verified English nameCXSL2600519 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
114 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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