YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 312 drug applications between 22 August 2024 and 28 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 61 drug names.
2024/08/22 – 2024/08/28
- New acceptances this week
- 312
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 1
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
312filings, 79 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 135 |
| Generic | 79 |
| New drug | 48 |
| Unspecified | 20 |
| Import | 18 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 194 |
| TCM | 70 |
| Therapeutic biologic | 37 |
| Biologic | 6 |
| 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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Bumetanide Injection | 4 | 2 | 13 |
| 2 | Riociguat Tablets | 3 | 1 | 4 |
| 3 | Vonoprazan Fumarate Tablets | 2 | 2 | 60 |
| 4 | Nicardipine Hydrochloride Injection | 2 | 2 | 13 |
| 5 | Dapoxetine Hydrochloride Tablets | 2 | 2 | 20 |
| 6 | Salbutamol Sulfate injection | 2 | 2 | 1 |
| 7 | Lactulose Oral Solution | 2 | 1 | 34 |
| 8 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 9 | Empagliflozin Tablets | 2 | 1 | 18 |
| 10 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen Research & Development LLC | 7 | 2 | 0 |
| 2 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 5 | Novo Nordisk A/S | 5 | 1 | 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 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Novo Nordisk Pharma AG | 4 | 1 | 0 |
| 10 | Health Pharma (Zhongguo) 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/08/28Generic · Class 3 | Bumetanide InjectionCYHS2402797 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
| 2024/08/28Generic · Class 3 | 盐酸尼卡地平氯化钠注射液 · No verified English nameCYHS2402794 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/08/28Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2402793 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2024/08/28Generic · Class 3 | Salbutamol Sulfate injectionCYHS2402792 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2024/08/28Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHL2400178 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/28Generic · Class 3 | 磷酸芦可替尼乳膏 · No verified English nameCYHL2400177 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2024/08/28New drug · Class 1 | 乐德奇拜单抗注射液 · No verified English nameCXSL2400573 | Xian Sheng Pharma Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | 9MW2821 · No verified English nameCXSL2400572 | Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | DR10624注射液 · No verified English nameCXSL2400571 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 3.3 | 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2400570 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | JYP0061片 · No verified English nameCXHL2400873 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | JYP0061片 · No verified English nameCXHL2400872 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | JYP0061片 · No verified English nameCXHL2400871 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2400870 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2400869 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Chengdu Wei Xin Pharma Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | AD101软膏 · No verified English nameCXHL2400868 | Shenzhen Ling Yi Sheng Ming Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | AD101软膏 · No verified English nameCXHL2400867 | Shenzhen Ling Yi Sheng Ming Technology Co., Ltd. romanized |
| 2024/08/28New drug · Class 1 | AD101软膏 · No verified English nameCXHL2400866 | Shenzhen Ling Yi Sheng Ming Technology Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Bromhexine Hydrochloride InjectionCYHS2402789 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Azilsartan and Amlodipine TabletsCYHS2402787 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Bumetanide InjectionCYHS2402785 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402784 | Chengdu Hua Yu Pharmaceutical Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Bumetanide InjectionCYHS2402783 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Salbutamol Sulfate injectionCYHS2402782 | Henan Pu Rui Pharma Co., Ltd. romanized |
| 2024/08/27Generic · Class 3 | Metronidazole TabletsCYHS2402779 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
63 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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