YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 409 drug applications between 25 November 2024 and 1 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 67 drug names.
2024/11/25 – 2024/12/01
- New acceptances this week
- 409
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- 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
409filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 208 |
| Generic | 92 |
| New drug | 54 |
| Import re-registration | 27 |
| Import | 18 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 280 |
| TCM | 82 |
| Therapeutic biologic | 40 |
| Biologic | 5 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mivacurium Chloride Injection | 4 | 2 | 3 |
| 2 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 3 | 氧 · No verified English name | 3 | 3 | 15 |
| 4 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 5 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 3 | 3 | 8 |
| 6 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 7 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 8 | Sildenafil Citrate Oral Disintegrating Tablets | 2 | 2 | 8 |
| 9 | Clopidogrel Hydrogen Sulphate Tablets | 2 | 2 | 6 |
| 10 | Bumetanide Injection | 2 | 1 | 13 |
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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Deutschland GmbH | 18 | 1 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 14 | 4 | 0 |
| 3 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 9 | 9 | 0 |
| 4 | AstraZeneca AB | 7 | 4 | 0 |
| 5 | The Wellcome Foundation Limited | 7 | 2 | 0 |
| 6 | Hunan Dong Ting Pharma Co., Ltd. romanized | 6 | 4 | 0 |
| 7 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Guangxi He Feng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 5 | 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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/30Import · Class 1 | 镥[177Lu]Lu-NeoB注射液 · No verified English nameJXHL2400281 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/11/30Import · Class 1 | 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒 · No verified English nameJXHL2400280 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/11/30Import · Class 1 | 注射用JX10 · No verified English nameJXHL2400279 | Corxel Pharmaceuticals Inc.; Corxel Pharmaceuticals (Shanghai) Co. Ltd |
| 2024/11/30Generic · Class 3 | Hydrotalcite SuspensionCYHS2404126 | Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2024/11/30Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2404125 | Chongqing Ben Li Fang Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2024/11/30Generic · Class 3 | Lanthanum Carbonate Hydrate GranulesCYHS2404124 | HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2024/11/30Generic · Class 3 | Enalapril Maleate Oral SolutionCYHS2404123 | Beijing Hai Yi Pharma Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/11/30Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2404122 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2024/11/30Generic · Class 3 | Paracetamol GranulesCYHS2404121 | Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized |
| 2024/11/30Generic · Class 3 | 吲哚美辛凝胶贴膏 · No verified English nameCYHL2400238 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2024/11/30Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400237 | Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | LYN101注射液 · No verified English nameCXSL2400810 | Shanghai Cai Zhi Yao Cheng Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | NKC007细胞注射液 · No verified English nameCXSL2400809 | Guangzhou En Kai Sai Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | KYS202002A注射液 · No verified English nameCXSL2400808 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401304 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401303 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401302 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2401301 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | HS-10502片 · No verified English nameCXHL2401300 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | HS-10502片 · No verified English nameCXHL2401299 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 2.4 | 泽布替尼胶囊 · No verified English nameCXHL2401298 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 2.4 | 泽布替尼胶囊 · No verified English nameCXHL2401297 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | F1F3软膏 · No verified English nameCXHL2401296 | Zhong Ao Biopharmaceuticals Technology (Guangdong) Co., Ltd. romanized |
| 2024/11/30New drug · Class 1 | F1F3软膏 · No verified English nameCXHL2401295 | Zhong Ao Biopharmaceuticals Technology (Guangdong) Co., Ltd. romanized |
| 2024/11/30New drug · Class 2.4 | 天麻素注射液 · No verified English nameCXHL2401294 | Kun Yao Group Co., Ltd. romanized; Kun Yao Group (Zhuhai Heng Qin) Technology Co., Ltd. romanized |
| 2024/11/29Import · Class 2.4 | DS-3201b片 · No verified English nameJXHL2400278 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/11/29Import · Class 2.4 | DS-3201b片 · No verified English nameJXHL2400277 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/11/29Import · Class 2.4 | DS-3201b片 · No verified English nameJXHL2400276 | Daiichi Sankyo Inc; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/11/29Import · Class 1 | BAY 2927088片 · No verified English nameJXHL2400275 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2024/11/29Import · Class 1 | BAY 2927088片 · No verified English nameJXHL2400274 | Bayer AG; Bayer Healthcare Company Ltd. |
64 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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