YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 412 drug applications between 21 November 2024 and 27 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 109, covering 83 drug names.
2024/11/21 – 2024/11/27
- New acceptances this week
- 412
- Drugs with new generic filings (by drug name, de-duplicated)
- 83
- Accepted this week, now under review
- 4
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
412filings, 109 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 109 |
| New drug | 61 |
| Import re-registration | 30 |
| Import | 16 |
| Unspecified | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 279 |
| TCM | 77 |
| Therapeutic biologic | 46 |
| Biologic | 5 |
| Prophylactic biologic | 5 |
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
83 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 | Sildenafil Citrate Oral Disintegrating Tablets | 2 | 2 | 8 |
| 5 | Oxybuprocaine Hydrochloride Eye Drops | 2 | 2 | 10 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 8 | Adapalene Gel | 2 | 2 | 30 |
| 9 | 双氯芬酸钠贴剂 · No verified English name | 2 | 1 | 0 |
| 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 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 13 | 6 | 0 |
| 3 | Novo Nordisk A/S | 10 | 1 | 0 |
| 4 | AstraZeneca AB | 7 | 3 | 0 |
| 5 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 6 | Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized | 6 | 5 | 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 | Yangtze River Pharmaceutical Group Co., Ltd | 5 | 5 | 0 |
| 10 | Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized | 5 | 5 | 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 |
|---|---|---|
| 2024/11/27Import · 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 |
| 2024/11/27New drug · Class 2.4 | Chidamide TabletsCXHL2401285 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2024/11/27New drug · Class 1 | TYK-00540片 · No verified English nameCXHL2401284 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2024/11/27New drug · Class 1 | TYK-00540片 · No verified English nameCXHL2401283 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized |
| 2024/11/26Import · Class 1 | 盐酸阿曲生坦片 · No verified English nameJXHS2400103 | Novartis Pharma Schweiz AG; AbbVie Ireland NL B.V. |
| 2024/11/26Import · Class 1 | Fosmanogepix注射液 · No verified English nameJXHL2400273 | Basilea Pharmaceutica International Ltd Allschwil; PAREXEL CHINA CO. LTD |
| 2024/11/26Import · Class 1 | Fosmanogepix片 · No verified English nameJXHL2400272 | Basilea Pharmaceutica International Ltd Allschwil; PAREXEL CHINA CO. LTD |
| 2024/11/26Import · Class 1 | Fosmanogepix片 · No verified English nameJXHL2400271 | Basilea Pharmaceutica International Ltd Allschwil; PAREXEL CHINA CO. LTD |
| 2024/11/26Generic · Class 3 | Pamidronate Disodium InjectionCYHS2404061 | Hebei Hui De Xu Sheng Pharmaceuticals Technology Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2024/11/26Generic · Class 3 | Minoxidil LinimentCYHS2404057 | Hefei Yuan Zhi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2024/11/26Generic · Class 3 | Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2404056 | Guangdong Wan Tai Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/11/26Generic · Class 3 | Bumetanide InjectionCYHS2404055 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/11/26Generic · Class 3 | Bumetanide InjectionCYHS2404054 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/11/26New drug · Class 3.3 | 乌司奴单抗注射液 · No verified English nameCXSS2400130 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/11/26New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2400800 | Zhengzhou Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized |
| 2024/11/26New drug · Class 3.4 | 人纤维蛋白原 · No verified English nameCXSL2400799 | Zhengzhou Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized |
| 2024/11/26New drug · Class 2.4 | 注射用BAT1006 · No verified English nameCXSL2400798 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/11/26New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400126 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2024/11/26New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400125 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2024/11/26New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400124 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2024/11/26New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400123 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2024/11/26New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400122 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized |
| 2024/11/26New drug · Class 2.2 | 苯磺酸氨氯地平颗粒 · No verified English nameCXHS2400121 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized; Yi Chang Dong Yang Guang Chang Jiang Pharma 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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