YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 17 December 2021 and 23 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 40 drug names.
2021/12/17 – 2021/12/23
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- 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
338filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| New drug | 76 |
| Generic | 59 |
| Unspecified | 14 |
| Import | 13 |
| Import re-registration | 13 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| Therapeutic biologic | 69 |
| TCM | 28 |
| In vitro diagnostic reagent | 4 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
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
40 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Febuxostat Tablets | 5 | 3 | 12 |
| 2 | Valsartan and Amlodipine Tablets(I) | 2 | 2 | 2 |
| 3 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 4 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 5 | Eplerenone Tablets | 2 | 1 | 4 |
| 6 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 7 | Elagolix Tablets | 2 | 1 | 2 |
| 8 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 9 | Tegafur,Gimeracil and Oteracil Potassium Capsules | 2 | 1 | 0 |
| 10 | Gemcitabine Hydrochloride for Injection | 2 | 1 | 1 |
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
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Anhui Shuang He Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 7 | 2 | 0 |
| 3 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Novo Nordisk A/S | 6 | 2 | 0 |
| 5 | Lv Shi Zi (Zhongguo) Bio Zhi Pin Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Pfizer Europe MA EEIG | 5 | 4 | 0 |
| 8 | Qilu Pharmaceutical (Hainan) Co., Ltd | 5 | 3 | 5 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Suzhou Hua Yi Mei Bio Technology Co., Ltd. romanized | 4 | 4 | 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/23Import · Class 1 | IMG-020注射液 · No verified English nameJXSL2101150 | Affibody AB; Inmagene Biopharmaceuticals (Wuhan) Co. Ltd. |
| 2021/12/23Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2102264 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2102263 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Ambroxol Hydrochloride Oral SolutionCYHS2102261 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2102258 | Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Tian Rui Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | 奥美拉唑碳酸氢钠胶囊(II) · No verified English nameCYHS2102257 | Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Compound Sulfamethoxazole TabletsCYHS2102256 | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Biapenem For InjectionCYHS2102250 | Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanized |
| 2021/12/23Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2102232 | Health Yuan Pharma Group Co., Ltd. romanized; Shenzhen Tai Tai Pharma Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2101084 | Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | 注射用重组人凝血因子Ⅷ-Fc融合蛋白 · No verified English nameCXSS2101083 | Jiangsu Cheng Si Biopharmaceutical Co., Ltd. romanized; Ao Si Kang Bio (Nan Tong) Co., Ltd. romanized |
| 2021/12/23New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSS2101072 | Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSS2101071 | Kang Ning Jie Rui (Jilin) Bio Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 2.1 | JS001sc注射液 · No verified English nameCXSL2101506 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 2.4 | 注射用BAT4306F · No verified English nameCXSL2101504 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/12/23New drug · Class 2.3 | LJ01003 · No verified English nameCXHL2101806 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 2.3 | LJ01003 · No verified English nameCXHL2101805 | Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2101804 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2101803 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2101802 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2021/12/23New drug · Class 2.2 | BCM332缓释片 · No verified English nameCXHL2101801 | Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | JK0002乳膏 · No verified English nameCXHL2101800 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | JK0002乳膏 · No verified English nameCXHL2101799 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 1 | JK0002乳膏 · No verified English nameCXHL2101798 | Shenzhen Jia Ke Bio Technology Co., Ltd. romanized |
| 2021/12/23New drug · Class 2.2 | 盐酸帕洛诺司琼口颊膜 · No verified English nameCXHL2101787 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 2021/12/23New drug · Class 2.2 | 盐酸帕洛诺司琼口颊膜 · No verified English nameCXHL2101786 | Li Pin Pharma (Xiamen) Co., Ltd. romanized |
| 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. |
79 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.