YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 333 drug applications between 16 December 2021 and 22 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 30 drug names.
2021/12/16 – 2021/12/22
- New acceptances this week
- 333
- Drugs with new generic filings (by drug name, de-duplicated)
- 30
- 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
333filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 167 |
| New drug | 79 |
| Generic | 48 |
| Import | 14 |
| Import re-registration | 14 |
| Unspecified | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 248 |
| Therapeutic biologic | 54 |
| TCM | 24 |
| In vitro diagnostic reagent | 4 |
| 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
30 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Febuxostat Tablets | 3 | 2 | 12 |
| 2 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 3 | 地氯雷他定口服溶液 · No verified English name | 2 | 2 | 26 |
| 4 | Valsartan and Amlodipine Tablets（I） | 2 | 2 | 2 |
| 5 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 6 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 7 | Eplerenone Tablets | 2 | 1 | 4 |
| 8 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 9 | Elagolix Tablets | 2 | 1 | 2 |
| 10 | Ozagrel Sodium Injection | 2 | 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
175 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Run Shuang He Pharma Co., Ltd. romanized | 24 | 21 | 1 |
| 2 | Anhui Shuang He Pharma Co., Ltd. romanized | 11 | 3 | 0 |
| 3 | Zhengzhou Yu Gang Zhi Xing Pharmaceutical Co., Ltd. romanized | 10 | 9 | 0 |
| 4 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Pfizer Europe MA EEIG | 5 | 4 | 0 |
| 6 | Qilu Pharmaceutical (Hainan) Co., Ltd | 5 | 3 | 5 |
| 7 | Eli Lilly and Company | 5 | 2 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Novartis Pharma Schweiz AG | 4 | 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/22Import · Class 2.2 | 注射用Loncastuximab tesirine · No verified English nameJXSL2101149 | ADC Therapeutics SA; Overland Pharmaceuticals (Shanghai) Co. Ltd. |
| 2021/12/22Import · Class 1 | Nipocalimab注射液 · No verified English nameJXSL2101148 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/12/22Import · Class 2.4 | Ruxolitinib Phosphate TabletsJXHL2101281 | Novartis Pharma Schweiz AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2021/12/22Import · Class 1 | LTT462胶囊 · No verified English nameJXHL2101280 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/12/22Import · Class 1 | HDM201胶囊 · No verified English nameJXHL2101279 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/12/22Import · Class 1 | HDM201胶囊 · No verified English nameJXHL2101278 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/12/22Import · Class 1 | MRTX849片 · No verified English nameJXHL2101277 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/12/22Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2102246 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2021/12/22Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2102245 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2021/12/22Generic · Class 3 | Ozagrel Sodium InjectionCYHS2102243 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2021/12/22Generic · Class 3 | Ozagrel Sodium InjectionCYHS2102242 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2021/12/22Generic · Class 3 | Minoxidil Topical SolutionCYHS2102238 | Hainan Zhen Dong Bio Technology Co., Ltd. romanized; Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2021/12/22Generic · Class 3 | Minoxidil Topical SolutionCYHS2102237 | Hainan Zhen Dong Bio Technology Co., Ltd. romanized; Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2021/12/22Generic · Class 3 | Elagolix TabletsCYHL2101050 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2021/12/22Generic · Class 3 | Elagolix TabletsCYHL2101049 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2021/12/22New drug · Class 1.1 | 姜石颗粒 · No verified English nameCXZL2101040 | Zhongguo Pharmaceuticals Research Kai Fa Center Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2101077 | Jiangsu Tai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.3 | 地舒单抗注射液 · No verified English nameCXSS2101076 | Jiangsu Tai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.4 | 人促红素注射液 · No verified English nameCXSS2101075 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.4 | 人促红素注射液 · No verified English nameCXSS2101074 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.4 | 人促红素注射液 · No verified English nameCXSS2101073 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.4 | 人促红素注射液 · No verified English nameCXSS2101070 | Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/22New drug · Class 2 | 丙型肝炎病毒抗体诊断试剂盒（磁微粒化学发光法） · No verified English nameCXSS2101069 | Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized |
| 2021/12/22New drug · Class 2 | 人类免疫缺陷病毒抗原抗体诊断试剂盒（磁微粒化学发光法） · No verified English nameCXSS2101068 | Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized |
| 2021/12/22New drug · Class 2 | 梅毒螺旋体抗体诊断试剂盒（磁微粒化学发光法） · No verified English nameCXSS2101067 | Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized |
| 2021/12/22New drug · Class 2 | 乙型肝炎病毒表面抗原诊断试剂盒（磁微粒化学发光法） · No verified English nameCXSS2101066 | Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.3 | 托珠单抗注射液 · No verified English nameCXSS2101056 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2021/12/22New drug · Class 1 | 重组人胰高糖素样肽1修饰抗人葡萄糖依赖性促胰岛素释放肽受体的人源化单克隆抗体注射液 · No verified English nameCXSL2101501 | Hong Yun Hua Ning (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/22New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSL2101500 | Zhuhai Ji Bai Kang Bio Technology Co., Ltd. romanized |
| 2021/12/22New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2101499 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
83 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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