YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 411 drug applications between 22 November 2024 and 28 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 74 drug names.
2024/11/22 – 2024/11/28
- New acceptances this week
- 411
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 7
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
411filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 192 |
| Generic | 103 |
| New drug | 58 |
| Import re-registration | 30 |
| Import | 18 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 263 |
| TCM | 87 |
| Therapeutic biologic | 52 |
| Biologic | 5 |
| Prophylactic biologic | 4 |
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
74 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 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 6 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 7 | Sildenafil Citrate Oral Disintegrating Tablets | 2 | 2 | 8 |
| 8 | Clopidogrel Hydrogen Sulphate Tablets | 2 | 2 | 6 |
| 9 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 10 | Adapalene Gel | 2 | 2 | 30 |
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
233 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Deutschland GmbH | 18 | 1 | 0 |
| 2 | Novo Nordisk A/S | 10 | 1 | 0 |
| 3 | AstraZeneca AB | 9 | 5 | 0 |
| 4 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 8 | 8 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 6 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Guangxi He Feng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 5 | 4 | 0 |
| 10 | Amgen Inc. | 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/28Import · Class 1 | DS-1062a · No verified English nameJXSL2400231 | Daiichi Sankyo Inc. |
| 2024/11/28Import · Class 3.1 | Eflapegrastim注射液 · No verified English nameJXSL2400230 | Hanmi Pharm. Co. Ltd.; PAREXEL CHINA CO. LTD |
| 2024/11/28Import · Class 2.2 | 注射用戈沙妥珠单抗 · No verified English nameJXSL2400229 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2024/11/28Generic · Class 3 | Ketoconazole CreamCYHS2404101 | Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized |
| 2024/11/28Generic · Class 3 | Ketoconazole CreamCYHS2404100 | Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized |
| 2024/11/28Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2404084 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2024/11/28Generic · Class 3 | Vitamin K1 InjectionCYHS2404082 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2024/11/28New drug · Class 3.1 | 枇杷清肺颗粒 · No verified English nameCXZS2400036 | Hebei Wan Sui Pharma Co., Ltd. romanized |
| 2024/11/28New drug · Class 1 | IM19嵌合抗原受体T细胞注射液(IM19 CAR-T细胞注射液) · No verified English nameCXSS2400131 | Beijing Yi Miao Shen Zhou Biopharmaceuticals Co., Ltd. romanized; Beijing Yi Miao Medical Technology Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.2 | 夫那奇珠单抗注射液 · No verified English nameCXSL2400806 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.2 | 夫那奇珠单抗注射液 · No verified English nameCXSL2400805 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/28New drug · Class 1 | CM313(SC)注射液 · No verified English nameCXSL2400804 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2024/11/28New drug · Class 1 | GenSci120注射液 · No verified English nameCXSL2400803 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2024/11/28New drug · Class 1 | CM313(SC)注射液 · No verified English nameCXSL2400802 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2024/11/28New drug · Class 1 | INV-6452片 · No verified English nameCXHL2401293 | Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized |
| 2024/11/28New drug · Class 1 | INV-6452片 · No verified English nameCXHL2401292 | Guangdong Sheng Innovation Yao Zhuan Hua Yi Xue Research Institute Co., Ltd. romanized; Shenzhen Shi Yuan Li Sheng Ming Ke Xue Co., Ltd. romanized; Fo Shan Shi Yuan Li Bio Technology Co., Ltd. romanized; Shanghai Ju Yuan Bio Technology Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.2; 2.4 | 注射用JP-1366 · No verified English nameCXHL2401291 | Li Zhu Pharmaceuticals Group Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.2 | 利拉鲁肽注射液 · No verified English nameCXHL2401290 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.1 | AY-1001 · No verified English nameCXHL2401289 | An Yu Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.1 | AY-1001 · No verified English nameCXHL2401288 | An Yu Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.1 | AY-1001 · No verified English nameCXHL2401287 | An Yu Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2024/11/28New drug · Class 2.1 | AY-1001 · No verified English nameCXHL2401286 | An Yu Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2024/11/27Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSS2400104 | Janssen-Cilag International NV; Cilag AG; Xian Janssen Pharmaceutical Ltd. |
| 2024/11/27Import · Class 1 | Riliprubart注射液 · No verified English nameJXSL2400228 | Sanofi-aventis Recherche & Développement; Sanofi(China)Investment Co. Ltd. |
| 2024/11/27Generic · Class 3 | Morphine Sulfate and Naltrexone Hydrochloride Extended-release CapsulesCYHS2404077 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2024/11/27Generic · Class 3 | Morphine Sulfate and Naltrexone Hydrochloride Extended-release CapsulesCYHS2404075 | Chengdu Easton Biopharmaceuticals Co.,Ltd. |
| 2024/11/27Generic · Class 3 | 美洛昔康纳米晶注射液 · No verified English nameCYHS2404070 | Health Yuan Pharma Group Co., Ltd. romanized; Health Yuan Hai Bin Pharma Co., Ltd. romanized |
| 2024/11/27New drug · Class 1.1 | 星蒌承气颗粒 · No verified English nameCXZL2400080 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized |
| 2024/11/27New drug · Class 1 | SCT650C 注射液 · No verified English nameCXSL2400801 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2024/11/27New drug · Class 2.4 | 甲磺酸阿美替尼片 · No verified English nameCXHS2400127 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
74 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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