YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 361 drug applications between 7 November 2024 and 13 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 82 drug names.
2024/11/07 – 2024/11/13
- New acceptances this week
- 361
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- Accepted this week, now under review
- 9
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
361filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 157 |
| Generic | 119 |
| New drug | 59 |
| Import | 11 |
| Import re-registration | 10 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 270 |
| TCM | 44 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 9 |
| In vitro diagnostic reagent | 1 |
| Biologic | 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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Fluoxetine Hydrochloride Oral Solution | 4 | 1 | 0 |
| 3 | Nicergoline Tablets | 3 | 2 | 1 |
| 4 | Crisaborole Ointment | 2 | 2 | 26 |
| 5 | Dydrogesterone Tablets | 2 | 2 | 8 |
| 6 | Sodium sulfate, magnesium sulfate, and potassium chloride Tablets | 2 | 2 | 2 |
| 7 | Formoterol Fumarate Inhalation Solution | 2 | 2 | 5 |
| 8 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 9 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 10 | Moxifloxacin Hydrochloride Tablets | 2 | 2 | 11 |
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
224 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 14 | 13 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 7 | 4 | 2 |
| 3 | Chengdu Di Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | SANOFI WINTHROP INDUSTRIE | 5 | 3 | 0 |
| 5 | Guangdong Sunho Pharmaceutical Co., Ltd. | 5 | 3 | 0 |
| 6 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Jiangxi Shimei Pharmaceutical Co., Ltd | 4 | 2 | 4 |
| 10 | Changchun Jin Sai Pharma 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
113 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/13Generic · Class 3 | Fluoxetine Hydrochloride Oral SolutionCYHS2403883 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/11/13Generic · Class 3 | Fluoxetine Hydrochloride Oral SolutionCYHS2403882 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/11/13Generic · Class 3 | Fluoxetine Hydrochloride Oral SolutionCYHS2403881 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/11/13Generic · Class 3 | Fluoxetine Hydrochloride Oral SolutionCYHS2403880 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/11/13Generic · Class 3 | 复方维生素C聚乙二醇(3350)钠钾散 · No verified English nameCYHS2403878 | Hubei Lai Kang Medical Technology Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized |
| 2024/11/13Generic · Class 3 | 达普司他片 · No verified English nameCYHL2400222 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized |
| 2024/11/13Generic · Class 3 | Tartilelin TabletsCYHL2400221 | Jiangsu Du Rui Pharmaceutical Co., Ltd. romanized |
| 2024/11/13New drug · Class 1 | 注射用维拉苷酶β · No verified English nameCXSS2400119 | Bei Hai Kang Cheng (Shanghai) Bio Technology Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2024/11/13New drug · Class 3.3 | 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2400772 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/11/13New drug · Class 1 | HBM9378(SKB378)注射液 · No verified English nameCXSL2400771 | He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized; Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/13New drug · Class 1 | AZD0022 · No verified English nameCXHL2401229 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/11/13New drug · Class 1 | AZD0022 · No verified English nameCXHL2401228 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2024/11/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400219 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/11/12Import · Class 1 | Amlitelimab注射液 · No verified English nameJXSL2400218 | Sanofi-Aventis Recherche & Developpement; Sanofi (China) Investment Co. LTD |
| 2024/11/12Generic · Class 3 | Famotidine InjectionCYHS2403872 | Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Paracetamol and Caffeine TabletsCYHS2403871 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2403868 | Henan Hua Luo Kang Run Pharma Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Cilnidipine TabletsCYHS2403862 | Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/11/12Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2403861 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Aceclofenac TabletsCYHS2403858 | Guangdong Mai Heng Pharmaceuticals Research and Development Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Acetylcysteine TabletsCYHS2403857 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2403856 | Anhui Shuang He Pharma Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Potassium Aspartate And Magnesium Aspartate InjectionCYHS2403855 | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHL2400220 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/11/12Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHL2400219 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2024/11/12Generic · Class 3 | Cyclobenzaprine hydrochloride extended-release capsulesCYHL2400218 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2024/11/12Generic · Class 3 | Cyclobenzaprine hydrochloride extended-release capsulesCYHL2400217 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2024/11/12New drug · Class 1 | 注射用聚乙二醇化促血小板生成肽 · No verified English nameCXSL2400770 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2024/11/12New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2400769 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2024/11/12New drug · Class 1 | IBI3014 · No verified English nameCXSL2400768 | Xin Da Biopharmaceutical (Suzhou) 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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