YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 133 drug applications between 4 May 2021 and 10 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 9 drug names.
2021/05/04 – 2021/05/10
- New acceptances this week
- 133
- Drugs with new generic filings (by drug name, de-duplicated)
- 9
- 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
133filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 82 |
| New drug | 19 |
| Generic | 10 |
| Import | 10 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 79 |
| TCM | 34 |
| Therapeutic 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
9 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 2 | Olanzapine Tablets | 1 | 1 | 4 |
| 3 | 屈螺酮炔雌醇片(Ⅱ) · No verified English name | 1 | 1 | 1 |
| 4 | Teprenone Capsules | 1 | 1 | 5 |
| 5 | Glycerol Fructose And Sodium Chloride Injection | 1 | 1 | 3 |
| 6 | Ambroxol Hydrochloride Injection | 1 | 1 | 9 |
| 7 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 1 | 1 | 1 |
| 8 | Valsartan Film-Coated Tablets | 1 | 1 | 0 |
| 9 | Citicoline Sodium Injection | 1 | 1 | 3 |
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
79 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized | 29 | 29 | 0 |
| 2 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 3 | 1 | 0 |
| 3 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 3 | 1 | 0 |
| 4 | Xi Nan Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 5 | AstraZeneca AB | 2 | 2 | 0 |
| 6 | Bright Future Pharmaceuticals Factory | 2 | 2 | 0 |
| 7 | Arctic Vision (Hong Kong) Limited | 2 | 1 | 0 |
| 8 | Eli Lilly Nederland B.V. | 2 | 1 | 0 |
| 9 | Merck Sharp & Dohme Corp. | 2 | 1 | 0 |
| 10 | Sanofi-aventis groupe | 2 | 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
29 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 2021/05/10New drug · Class 2.4 | 注射用甲苯磺酸瑞马唑仑 · No verified English nameCXHL2101106 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/05/08Import · Class 2.2 | Benralizumab注射液 · No verified English nameJXSL2101022 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/05/08Import · Class 1 | U3-1402 · No verified English nameJXSL2101021 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2021/05/08Import · Class 2.2 | 硫酸阿托品滴眼液 · No verified English nameJXHL2101023 | Ocumension (Hong Kong)Limited; Ocumension Therapeutics(Shanghai)Co. Ltd |
| 2021/05/08Generic · Class 3 | Citicoline Sodium InjectionCYHS2101123 | Guangdong Sai Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/05/08New drug · Class 1 | 派安普利单抗注射液 · No verified English nameCXSL2101056 | Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/08New drug · Class 1 | UB-621注射液 · No verified English nameCXSL2101055 | Lian Yao (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/05/08New drug · Class 1 | 3D-229注射液 · No verified English nameCXSL2101049 | Xu Zhou Si Lu Di Pharma Co., Ltd. romanized |
| 2021/05/07New drug · Class 1 | REV001注射液 · No verified English nameCXSL2101053 | Shanghai Xing Shen Bio Technology Co., Ltd. romanized |
| 2021/05/07New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2101012 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/05/07New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2101011 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/05/07New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2101010 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/05/07New drug · Class 1 | 甲磺酸瑞泽替尼胶囊 · No verified English nameCXHS2101009 | Shanghai Bei Er Da Pharma Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2021/05/07New drug · Class 2.2 | 卡左双多巴控释片 · No verified English nameCXHL2101104 | Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/07New drug · Class 2.2 | 卡左双多巴控释片 · No verified English nameCXHL2101103 | Shanghai Han Dou Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/05/06Import · Class 1 | Efgartigimod注射液 · No verified English nameJXSL2101018 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/05/06New drug · Class 1 | BAT6005注射液 · No verified English nameCXSL2101052 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/05/06New drug · Class 1 | AZD4205胶囊 · No verified English nameCXHL2101102 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2021/05/06New drug · Class 1 | AZD4205胶囊 · No verified English nameCXHL2101101 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2021/05/06New drug · Class 2.2 | 雷美替胺双释片 · No verified English nameCXHL2101100 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2021/05/06New drug · Class 1 | 注射用硝酮嗪 · No verified English nameCXHL2101099 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
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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