YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 429 drug applications between 11 December 2024 and 17 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 117, covering 90 drug names.
2024/12/11 – 2024/12/17
- New acceptances this week
- 429
- Drugs with new generic filings (by drug name, de-duplicated)
- 90
- 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
429filings, 117 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 181 |
| Generic | 117 |
| New drug | 98 |
| Import | 21 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| TCM | 71 |
| Therapeutic biologic | 54 |
| Prophylactic biologic | 10 |
| 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
90 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 6 | 3 | 60 |
| 2 | Ambroxol Hydrochloride Oral Solution | 5 | 1 | 46 |
| 3 | Nafamostat Mesilate for Injection | 4 | 3 | 38 |
| 4 | 醋酸兰瑞肽缓释注射液(预充式) · No verified English name | 3 | 1 | 0 |
| 5 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 6 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 9 |
| 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 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 2 | 1 | 12 |
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
274 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 9 | 2 | 0 |
| 3 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 9 | 2 | 0 |
| 4 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 8 | 6 | 0 |
| 5 | Novo Nordisk A/S | 6 | 2 | 0 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 8 | Jiangxi Cheng Zhi Yong Feng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 4 | 3 |
| 10 | Fu Yuan Pharma Co., Ltd. romanized | 4 | 4 | 1 |
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
157 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/17Import · Class 1 | SAR402663注射液 · No verified English nameJXSL2400240 | Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD |
| 2024/12/17Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2404385 | Hubei Xin Ze Fei Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2404384 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/12/17Generic · Class 3 | Trimebutine Maleate TabletsCYHS2404381 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2024/12/17Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2404375 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2404373 | Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2404372 | Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2404371 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Epinephrine InjectionCYHS2404369 | Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Wuhan Jiu An Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2404368 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2404367 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Oxycodone And Acetaminophen TabletsCYHS2404364 | Beijing Hua Su Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Terlipressin Acetate InjectionCYHS2404363 | Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Nafamostat Mesilate for InjectionCYHL2400262 | Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Nafamostat Mesilate for InjectionCYHL2400261 | Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/17New drug · Class 1.1 | 散热止咳颗粒 · No verified English nameCXZL2400091 | Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized |
| 2024/12/17New drug · Class 1 | 伊诺格鲁肽注射液 · No verified English nameCXSS2400141 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | 伊诺格鲁肽注射液 · No verified English nameCXSS2400140 | Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | 注射用BGB-C354 · No verified English nameCXSL2400877 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2024/12/17New 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 nameCXSL2400876 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | LP-003 注射液 · No verified English nameCXSL2400875 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2024/12/17New drug · Class 3.3 | 水痘减毒活疫苗 · No verified English nameCXSL2400874 | Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | SYS6002 · No verified English nameCXSL2400873 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/12/17New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400872 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2400871 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/17New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2400870 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/17New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2400869 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | BIOT006片 · No verified English nameCXHL2401397 | Xiamen Bao Tai Bio Technology Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | BIOT006片 · No verified English nameCXHL2401396 | Xiamen Bao Tai Bio Technology Co., Ltd. romanized |
| 2024/12/17New drug · Class 1 | HW201877胶囊 · No verified English nameCXHL2401395 | Wuhan Ren Fu Innovation Drug Research and Development Center Co., Ltd. romanized |
127 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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