YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 215 drug applications between 6 May 2021 and 12 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 18 drug names.
2021/05/06 – 2021/05/12
- New acceptances this week
- 215
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
215filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| New drug | 28 |
| Generic | 23 |
| Import | 20 |
| Import re-registration | 8 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 132 |
| TCM | 44 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 5 |
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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Valsartan Film-Coated Tablets | 3 | 2 | 0 |
| 2 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 3 | Osimertinib Mesylate Tablets | 2 | 1 | 2 |
| 4 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 5 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 6 | Olanzapine Tablets | 1 | 1 | 4 |
| 7 | Olmesartan Medoxomil and Amlodipine Besylate Tablets | 1 | 1 | 2 |
| 8 | 屈螺酮炔雌醇片(Ⅱ) · No verified English name | 1 | 1 | 1 |
| 9 | Batroxobin Injection | 1 | 1 | 0 |
| 10 | Teprenone Capsules | 1 | 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
117 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized | 37 | 36 | 0 |
| 2 | AstraZeneca AB | 4 | 3 | 0 |
| 3 | Bright Future Pharmaceuticals Factory | 4 | 3 | 0 |
| 4 | Takeda Pharma A/S | 4 | 2 | 0 |
| 5 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 4 | 2 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | LTL Pharma Co. Ltd. | 4 | 1 | 0 |
| 8 | argenx BV | 3 | 2 | 0 |
| 9 | Bayer HealthCare LLC | 3 | 1 | 0 |
| 10 | Merck Sharp & Dohme Corp. | 3 | 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
51 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/05/12New drug · Class 1.1 | 颅通胶囊 · No verified English nameCXZL2101007 | Shanghai Lv Gu Sheng Ming Yuan Pharmaceuticals Co., Ltd. romanized |
| 2021/05/12New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101067 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/05/12New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101065 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/05/12New drug · Class 1 | SPH5030片 · No verified English nameCXHL2101114 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2021/05/12New drug · Class 1 | SPH5030片 · No verified English nameCXHL2101113 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2021/05/11Generic · Class 3 | Batroxobin InjectionCYHL2101007 | Hainan Xian Sheng Pharma Co., Ltd. romanized |
| 2021/05/11New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101060 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/05/11New drug · Class 1 | Ociperlimab注射液 · No verified English nameCXSL2101059 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2021/05/11New drug · Class 1 | HY-072808软膏 · No verified English nameCXHL2101110 | Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized |
| 2021/05/11New drug · Class 1 | 注射用HRS3797 · No verified English nameCXHL2101109 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/05/10Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2101006 | Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2021/05/10Import · Class 3.1 | 度普利尤单抗注射液 · No verified English nameJXSS2101005 | Sanofi-aventis groupe; Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd. |
| 2021/05/10Import · Class 2.2 | 硫酸阿托品微量眼用溶液 · No verified English nameJXHL2101025 | Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd |
| 2021/05/10Import · Class 2.2 | 硫酸阿托品微量眼用溶液 · No verified English nameJXHL2101024 | Arctic Vision (Hong Kong) Limited; Arctic Vision (Shanghai) Biotechnology Co Ltd |
| 2021/05/10Generic · Class 3 | Glycerol Fructose And Sodium Chloride InjectionCYHS2101134 | CISEN PHARMACEUTICAL CO., LTD. |
| 2021/05/10New drug · Class 1 | 泽贝妥单抗注射液 · No verified English nameCXSL2101057 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/05/10New drug · Class 1 | NTQ1062片 · No verified English nameCXHL2101108 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2021/05/10New drug · Class 1 | NTQ1062片 · No verified English nameCXHL2101107 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
21 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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