YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 442 drug applications between 8 December 2024 and 14 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 87 drug names.
2024/12/08 – 2024/12/14
- New acceptances this week
- 442
- Drugs with new generic filings (by drug name, de-duplicated)
- 87
- Accepted this week, now under review
- 6
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
442filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 195 |
| Generic | 119 |
| New drug | 94 |
| Import | 20 |
| Unspecified | 10 |
| Import re-registration | 3 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 301 |
| TCM | 68 |
| Therapeutic biologic | 56 |
| Prophylactic biologic | 9 |
| Biologic | 7 |
| In vitro diagnostic reagent | 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
87 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 14 | 7 | 60 |
| 2 | Ambroxol Hydrochloride Oral Solution | 5 | 1 | 46 |
| 3 | 醋酸兰瑞肽缓释注射液(预充式) · No verified English name | 3 | 1 | 0 |
| 4 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 5 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 9 |
| 6 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 7 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 8 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 9 | 布比卡因脂质体注射液 · No verified English name | 2 | 1 | 7 |
| 10 | Empagliflozin Tablets | 2 | 1 | 18 |
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
288 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 9 | 2 | 0 |
| 2 | Novo Nordisk A/S | 7 | 2 | 0 |
| 3 | Ya Bao Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 8 | Fu Yuan Pharma Co., Ltd. romanized | 4 | 4 | 1 |
| 9 | Tong Hua Zheng Yuan Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 2 |
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
147 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/14Import · Class 1 | Amycretin注射液 · No verified English nameJXSL2400237 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400111 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400110 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400109 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2400108 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/14Generic · Class 3 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2404359 | Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/12/14Generic · Class 3 | 头孢泊肟酯干混悬剂 · No verified English nameCYHS2404352 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/12/14Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2404350 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2024/12/14Generic · Class 3 | 复方聚乙二醇电解质散(II) · No verified English nameCYHS2404347 | Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/12/14Generic · Class 3 | Azilsartan and Amlodipine TabletsCYHL2400259 | Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2024/12/14New drug · Class 2.2 | 吸附无细胞百(三组分)白破联合疫苗 · No verified English nameCXSS2400139 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2024/12/14New drug · Class 3.3 | 阿达木单抗注射液 · No verified English nameCXSS2400138 | Zhejiang Hua Hai Bio Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | 注射用DXC008 · No verified English nameCXSL2400868 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400867 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2400866 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | 注射用SHR-4602 · No verified English nameCXSL2400865 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | 注射用KKD001 · No verified English nameCXSL2400864 | Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | 注射用KKD001 · No verified English nameCXSL2400863 | Shang Rao Shi Kang Ke De Bio Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | IMM01 · No verified English nameCXSL2400862 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | IMM2510 · No verified English nameCXSL2400861 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2024/12/14New drug · Class 1.2 | 冻干二价呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400860 | Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | 人骨髓间充质干细胞注射液 · No verified English nameCXSL2400859 | Jiu Zhi Tang Mei Ke (Beijing) Xi Bao Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | JMT108注射液 · No verified English nameCXSL2400858 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | JYP0015片 · No verified English nameCXHL2401384 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | JYP0015片 · No verified English nameCXHL2401383 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | JYP0015片 · No verified English nameCXHL2401382 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | JYP0015片 · No verified English nameCXHL2401381 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | JYP0015片 · No verified English nameCXHL2401380 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | JYP0015片 · No verified English nameCXHL2401379 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/14New drug · Class 1 | CXJM-66注射液 · No verified English nameCXHL2401378 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
117 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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