YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 323 drug applications between 23 August 2024 and 29 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 60 drug names.
2024/08/23 – 2024/08/29
- New acceptances this week
- 323
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 0
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
323filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 143 |
| Generic | 80 |
| New drug | 57 |
| Import | 18 |
| Unspecified | 13 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 198 |
| TCM | 66 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 8 |
| Biologic | 6 |
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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 6 | 3 | 13 |
| 2 | Riociguat Tablets | 3 | 1 | 4 |
| 3 | 洛索洛芬钠凝胶贴膏 · No verified English name | 2 | 2 | 9 |
| 4 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 5 | Salbutamol Sulfate injection | 2 | 2 | 1 |
| 6 | 维生素B12滴眼液 · No verified English name | 2 | 2 | 2 |
| 7 | Lactulose Oral Solution | 2 | 1 | 34 |
| 8 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 9 | Empagliflozin Tablets | 2 | 1 | 18 |
| 10 | Sildenafil Citrate 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
210 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen Research & Development LLC | 7 | 2 | 0 |
| 2 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Novo Nordisk A/S | 5 | 1 | 0 |
| 5 | Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 7 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
| 8 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Novo Nordisk Pharma AG | 4 | 1 | 0 |
| 10 | Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized | 3 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/29Generic · Class 3 | Fludeoxyglucose[18F] InjectionCYHS2402816 | Guangzhou Shi Yuan Zi Gao Ke Tong Wei Su Pharmaceuticals Co., Ltd. romanized |
| 2024/08/29Generic · Class 3 | Diprophylline InjectionCYHS2402813 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2024/08/29Generic · Class 3 | Pregabalin Oral SolutionCYHS2402812 | Guangdong He Wei Pharmaceutical Co., Ltd. romanized |
| 2024/08/29Generic · Class 3 | Magnesium Sulfate InjectionCYHS2402809 | Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/08/29Generic · Class 3 | Bumetanide InjectionCYHS2402806 | Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2024/08/29Generic · Class 3 | Bumetanide InjectionCYHS2402805 | Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized |
| 2024/08/29New drug · Class 2.2 | 九价人乳头瘤病毒疫苗(大肠埃希菌) · No verified English nameCXSL2400580 | Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized; Xiamen University romanized |
| 2024/08/29New drug · Class 1 | KQ-2002 CAR-T细胞注射液 · No verified English nameCXSL2400579 | Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | KQ-2002 CAR-T细胞注射液 · No verified English nameCXSL2400578 | Ke Yi (Zhejiang) Pharma Technology Co., Ltd. romanized |
| 2024/08/29New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400577 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | 注射用SHR-9839 · No verified English nameCXSL2400576 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | SHR-7367注射液 · No verified English nameCXSL2400575 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | TQC2731注射液 · No verified English nameCXSL2400574 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | 注射用甲苯磺酸钠烟酰胺腙聚乙二醇双环RGD肽 · No verified English nameCXHS2400087 | Fo Shan Rui Di Ao Pharmaceuticals Co., Ltd. romanized; Beijing Shi Hong Pharma Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | 锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液 · No verified English nameCXHS2400086 | Fo Shan Rui Di Ao Pharmaceuticals Co., Ltd. romanized; Jiangsu Hua Yi Technology Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | 琥珀八氢氨吖啶片 · No verified English nameCXHS2400085 | Tong Hua Jin Ma Pharma Group Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | 琥珀八氢氨吖啶片 · No verified English nameCXHS2400084 | Tong Hua Jin Ma Pharma Group Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | LDR2402注射液 · No verified English nameCXHL2400881 | Chengdu Xian Yan Bio Technology Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | AC-201片 · No verified English nameCXHL2400880 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | TQH3906胶囊 · No verified English nameCXHL2400879 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | TQH3906胶囊 · No verified English nameCXHL2400878 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2400877 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | 注射用JMKX003676 · No verified English nameCXHL2400876 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2024/08/29New drug · Class 2.2 | HQ2216注射液 · No verified English nameCXHL2400875 | Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2024/08/29New drug · Class 1 | SBK007片 · No verified English nameCXHL2400874 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/28Import · Class 3.1 | 替利珠单抗注射液 · No verified English nameJXSS2400070 | Provention Bio Inc.; Ajinomoto Althea Inc.; Sanofi (China) Investment Co. Ltd. |
| 2024/08/28Import · Class 1 | BI 1015550 片 · No verified English nameJXHL2400210 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/08/28Import · Class 1 | BI 1015550 片 · No verified English nameJXHL2400209 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/08/28Generic · Class 3 | 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2402802 | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2024/08/28Generic · Class 3 | Bumetanide InjectionCYHS2402798 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
72 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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