YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 222 drug applications between 7 May 2021 and 13 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 20 drug names.
2021/05/07 – 2021/05/13
- New acceptances this week
- 222
- Drugs with new generic filings (by drug name, de-duplicated)
- 20
- Accepted this week, now under review
- 0
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
222filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 119 |
| New drug | 35 |
| Generic | 27 |
| Import | 27 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 151 |
| Therapeutic biologic | 34 |
| TCM | 32 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 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
20 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 3 | 2 | 1 |
| 2 | Tadalafil Tablets | 2 | 1 | 23 |
| 3 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 4 | Osimertinib Mesylate Tablets | 2 | 1 | 2 |
| 5 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 6 | Valsartan Film-Coated Tablets | 2 | 1 | 0 |
| 7 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 8 | Olmesartan Medoxomil and Amlodipine Besylate Tablets | 1 | 1 | 2 |
| 9 | 屈螺酮炔雌醇片(Ⅱ) · No verified English name | 1 | 1 | 1 |
| 10 | Batroxobin Injection | 1 | 1 | 0 |
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
121 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized | 24 | 23 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 3 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 5 | 2 | 0 |
| 5 | AstraZeneca AB | 4 | 3 | 0 |
| 6 | Bright Future Pharmaceuticals Factory | 4 | 3 | 0 |
| 7 | Takeda Pharma A/S | 4 | 2 | 0 |
| 8 | Shanghai Pharmaceuticals Group Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 4 | 2 | 0 |
| 10 | LTL Pharma Co. Ltd. | 4 | 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
63 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/13Import · Class 1 | 巴替利单抗注射液 · No verified English nameJXSL2101016 | Agenus Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2021/05/13Import · Class 1 | TAK-935片 · No verified English nameJXHL2101036 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/05/13Import · Class 1 | TAK-935片 · No verified English nameJXHL2101035 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/05/13Import · Class 1 | TAK-935片 · No verified English nameJXHL2101034 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/05/13Import · Class 1 | TAK-935片 · No verified English nameJXHL2101033 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd. |
| 2021/05/13Import · Class 1 | GDC-9545 · No verified English nameJXHL2101017 | F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd. |
| 2021/05/13New drug · Class 1 | 重组人源化抗Trop2单抗-SN38偶联物 · No verified English nameCXSL2101069 | Shanghai Shi Jian Bio Technology Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | PM8003注射液 · No verified English nameCXSL2101066 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2021/05/13New drug · Class 2.4 | 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHS2101005 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | 苯乙基异硫氰酸酯液体硬胶囊 · No verified English nameCXHL2101120 | Wuxi Jie Xi Pharmaceuticals Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | IN10018片 · No verified English nameCXHL2101119 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | IN10018片 · No verified English nameCXHL2101118 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | SPH3127片 · No verified English nameCXHL2101117 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | SPH3127片 · No verified English nameCXHL2101116 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | HSK21542注射液 · No verified English nameCXHL2101115 | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | HTMC0370片 · No verified English nameCXHL2101112 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | HTMC0370片 · No verified English nameCXHL2101111 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/05/13New drug · Class 1 | SBK001注射液 · No verified English nameCXHL2101105 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/12Import · Class 2.2 | 注射用维得利珠单抗 · No verified English nameJXSL2101026 | Takeda Development Center Americas Inc. |
| 2021/05/12Import · Class 1 | Efgartigimod浓缩注射液 · No verified English nameJXSL2101024 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/05/12Import · Class 1 | Efgartigimod注射液 · No verified English nameJXSL2101023 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/05/12Import · Class 1 | NMS-03305293胶囊 · No verified English nameJXHL2101032 | Nerviano Medical Sciences S.r.l.; PPC China Corporation Limited |
| 2021/05/12Import · Class 1 | Lerociclib片 · No verified English nameJXHL2101031 | G1 Therapeutics Inc.; Genor Biopharma Co. Ltd |
| 2021/05/12Import · Class 1 | NMS-03305293胶囊 · No verified English nameJXHL2101030 | Nerviano Medical Sciences S.r.l.; PPC China Corporation Limited |
| 2021/05/12Import · Class 1 | Lerociclib片 · No verified English nameJXHL2101029 | G1 Therapeutics Inc.; Genor Biopharma Co. Ltd |
| 2021/05/12Import · Class 2.4 | BYL719 · No verified English nameJXHL2101028 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/05/12Import · Class 2.4 | BYL719 · No verified English nameJXHL2101027 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/05/12Import · Class 2.4 | BYL719 · No verified English nameJXHL2101026 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/05/12Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2101143 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2021/05/12Generic · Class 3 | Metoprolol Tartrate InjectionCYHS2101142 | Zhejiang You Sheng Mei Te Zhong Yao Co., Ltd. romanized |
33 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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