YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 259 drug applications between 8 May 2021 and 14 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 22 drug names.
2021/05/08 – 2021/05/14
- New acceptances this week
- 259
- Drugs with new generic filings (by drug name, de-duplicated)
- 22
- 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
259filings, 32 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 135 |
| New drug | 47 |
| Generic | 32 |
| Import | 31 |
| Import re-registration | 10 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 177 |
| Therapeutic biologic | 48 |
| TCM | 27 |
| Prophylactic biologic | 6 |
| 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
22 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 2 | 23 |
| 2 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 3 | 2 | 1 |
| 3 | Clindamycin Injection | 3 | 1 | 4 |
| 4 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 5 | Osimertinib Mesylate Tablets | 2 | 1 | 2 |
| 6 | Oseltamivir Phosphate Capsules | 2 | 1 | 39 |
| 7 | Valsartan Film-Coated Tablets | 2 | 1 | 0 |
| 8 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 9 | 地氯雷他定口服溶液 · No verified English name | 1 | 1 | 26 |
| 10 | Olmesartan Medoxomil and Amlodipine Besylate Tablets | 1 | 1 | 2 |
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
134 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized | 20 | 19 | 0 |
| 2 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. | 15 | 10 | 0 |
| 3 | Qilu Pharmaceutical Co., Ltd. | 6 | 3 | 0 |
| 4 | Takeda Development Center Americas Inc. | 6 | 2 | 0 |
| 5 | AstraZeneca AB | 5 | 4 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Novartis Pharma AG | 5 | 2 | 0 |
| 8 | Bright Future Pharmaceuticals Factory | 4 | 3 | 0 |
| 9 | Takeda Pharma A/S | 4 | 2 | 0 |
| 10 | Shanghai Pharmaceuticals Group Co., Ltd. romanized | 4 | 2 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/14Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2101027 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2021/05/14Import · Class 2.2 | 注射用维得利珠单抗 · No verified English nameJXSL2101025 | Takeda Development Center Americas Inc. |
| 2021/05/14Import · Class 1 | ZN-d5片 · No verified English nameJXHL2101039 | Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd |
| 2021/05/14Import · Class 1 | ZN-d5片 · No verified English nameJXHL2101038 | Zentera Therapeutics HK Limited; Zentera Therapeutics Shanghai Co. Ltd |
| 2021/05/14Import · Class 1 | Cotadutide注射液 · No verified English nameJXHL2101037 | AstraZeneca AB; AstraZeneca Investment (China)Co. Ltd. |
| 2021/05/14Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2101158 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2021/05/14Generic · Class 3 | Tofacitinib Citrate Extended Release tabletsCYHS2101133 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2021/05/14Generic · Class 3 | Clindamycin InjectionCYHS2101129 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2021/05/14Generic · Class 3 | Clindamycin InjectionCYHS2101128 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2021/05/14Generic · Class 3 | Clindamycin InjectionCYHS2101127 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized |
| 2021/05/14New drug · Class 1.2 | 重组带状疱疹疫苗(CHO 细胞) · No verified English nameCXSL2101078 | Beijing Lv Zhu Bio Technology Co., Ltd. romanized |
| 2021/05/14New drug · Class 1.2 | 重组带状疱疹疫苗(CHO 细胞) · No verified English nameCXSL2101077 | Beijing Lv Zhu Bio Technology Co., Ltd. romanized |
| 2021/05/14New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101076 | Tai Zhou Han Zhong Biopharmaceuticals Co., Ltd. romanized |
| 2021/05/14New drug · Class 1 | BR102注射液 · No verified English nameCXSL2101075 | Hai Zheng Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2101074 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.2 | IBI310 · No verified English nameCXSL2101073 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/05/14New drug · Class 1 | 注射用QLS31905 · No verified English nameCXSL2101072 | Qilu Pharmaceutical Co., Ltd. |
| 2021/05/14New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101064 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101063 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101062 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.2 | 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2101061 | Wei Shi Pharma (Ru Gao) Co., Ltd. romanized |
| 2021/05/14New drug · Class 1 | 6MW3211 注射液 · No verified English nameCXSL2101058 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/05/14New drug · Class 1 | 注射用TQB2825 · No verified English nameCXSL2101054 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.2 | 波生坦口崩片 · No verified English nameCXHL2101127 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.2 | 波生坦口崩片 · No verified English nameCXHL2101126 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.3 | NHKC-1 · No verified English nameCXHL2101125 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2021/05/14New drug · Class 2.3 | NHKC-1 · No verified English nameCXHL2101124 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2021/05/14New drug · Class 1 | BT-101094胶囊 · No verified English nameCXHL2101123 | Chengdu Hai Bo Rui Pharma Co., Ltd. romanized |
| 2021/05/14New drug · Class 1 | BT-101094胶囊 · No verified English nameCXHL2101122 | Chengdu Hai Bo Rui Pharma Co., Ltd. romanized |
| 2021/05/13Import · Class 1 | 巴替利单抗注射液 · No verified English nameJXSL2101016 | Agenus Inc.; Betta Pharmaceuticals Co. Ltd. |
55 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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