YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 372 drug applications between 13 December 2024 and 19 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 75 drug names.
2024/12/13 – 2024/12/19
- New acceptances this week
- 372
- Drugs with new generic filings (by drug name, de-duplicated)
- 75
- Accepted this week, now under review
- 5
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
372filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 96 |
| New drug | 79 |
| Import | 22 |
| Import re-registration | 7 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 81 |
| Therapeutic biologic | 62 |
| 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
75 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride Oral Solution | 5 | 1 | 46 |
| 2 | Nafamostat Mesilate for Injection | 4 | 3 | 38 |
| 3 | Procaterol Hydrochloride Solution for Inhalation | 3 | 2 | 2 |
| 4 | 阿贝西利片 · No verified English name | 3 | 1 | 2 |
| 5 | Fusidic Acid Cream | 2 | 2 | 15 |
| 6 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 7 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 9 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 2 | 1 | 12 |
| 10 | Topiramate Tablets | 2 | 1 | 0 |
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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 12 | 10 | 0 |
| 2 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 9 | 2 | 0 |
| 3 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Fu Yuan Pharma Co., Ltd. romanized | 5 | 5 | 2 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Novartis Pharma AG | 5 | 2 | 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 | Janssen Research & Development LLC | 4 | 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
134 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/19Import · Class 1 | DS-3939a · No verified English nameJXSL2400242 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/12/19Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2404418 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2404417 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2404416 | Zhejiang Shang Ke Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | Magnesium Sulfate InjectionCYHS2404413 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | Magnesium Sulfate InjectionCYHS2404412 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2404411 | Henan Li Hua Pharmaceutical Co., Ltd. romanized; Henan Run Hong Pharmaceutical Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | 头孢克肟颗粒 · No verified English nameCYHS2404410 | Guangdong Hua Nan Pharma Group Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | Bumetanide InjectionCYHS2404407 | Yunnan Hua Pai Pharmaceuticals Technology Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | 环索奈德吸入气雾剂 · No verified English nameCYHS2404405 | Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized |
| 2024/12/19Generic · Class 3 | Bepotastine Besilate Orally Disintegrating TabletsCYHS2404404 | Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2024/12/19New drug · Class 1.1 | 小儿苓龙早熟颗粒 · No verified English nameCXZL2400094 | Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | OVV-01 注射液 · No verified English nameCXSL2400887 | Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | OVV-01 注射液 · No verified English nameCXSL2400886 | Shanghai Rong Rui Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | 注射用BR111 · No verified English nameCXSL2400885 | Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | IBI3007 · No verified English nameCXSL2400884 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | FT-003注射液 · No verified English nameCXSL2400883 | Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | 同种异体脂肪间充质基质细胞注射液 · No verified English nameCXSL2400882 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2024/12/19New drug · Class 3.2 | Catumaxomab注射液(卡妥索单抗注射液) · No verified English nameCXSL2400881 | Guangzhou Ling Teng Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/19New drug · Class 3.2 | Catumaxomab注射液(卡妥索单抗注射液) · No verified English nameCXSL2400880 | Guangzhou Ling Teng Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | HTMC0658片 · No verified English nameCXHL2401404 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | HTMC0658片 · No verified English nameCXHL2401403 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | TT-00420片 · No verified English nameCXHL2401402 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | TT-00420片 · No verified English nameCXHL2401401 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2024/12/19New drug · Class 1 | TT-00420片 · No verified English nameCXHL2401400 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2024/12/19New drug · Class 2.2 | 注射用BJ007(皮下注射) · No verified English nameCXHL2401399 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2024/12/19New drug · Class 2.4 | Esketamine Hydrochloride InjectionCXHL2401398 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/12/18Import · Class 1 | AZD4360 · No verified English nameJXSL2400241 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/18Import · Class 2.4 | 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2400296 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/18Import · Class 1 | KFA115 · No verified English nameJXHL2400295 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
104 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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