YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 298 drug applications between 18 August 2024 and 24 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 63 drug names.
2024/08/18 – 2024/08/24
- New acceptances this week
- 298
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 2
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
298filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| Generic | 92 |
| New drug | 36 |
| Unspecified | 21 |
| Import re-registration | 11 |
| Import | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 68 |
| Therapeutic biologic | 28 |
| Biologic | 12 |
| Prophylactic biologic | 2 |
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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 4 | 2 | 34 |
| 2 | Nicardipine Hydrochloride Injection | 4 | 2 | 13 |
| 3 | Oxacillin Sodium for Injection | 3 | 2 | 13 |
| 4 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 5 | Riociguat Tablets | 3 | 1 | 4 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 2 | 60 |
| 7 | Dapoxetine Hydrochloride Tablets | 2 | 2 | 20 |
| 8 | Sodium Bicarbonate Injection | 2 | 2 | 10 |
| 9 | Sodium Picosulfate Oral Solution | 2 | 1 | 0 |
| 10 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
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
193 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 10 | 1 | 0 |
| 2 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 3 | Guangxi Chan Fang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 4 | 0 |
| 5 | Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 6 | Anhui Pioneer Pharmaceutical Co., Ltd | 4 | 3 | 4 |
| 7 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Hubei Mei Lin Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Janssen Research & Development LLC | 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
77 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/24Import · Class 1 | Nivolumab/Relatlimab固定剂量复方注射液 · No verified English nameJXSL2400154 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2024/08/24Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2402775 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2024/08/24New drug · Class 1 | KYS202003A注射液 · No verified English nameCXSL2400562 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/08/24New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2400561 | Beijing Bei Lai Pharma Co., Ltd. romanized |
| 2024/08/24New drug · Class 2.4 | 苯环喹溴铵鼻喷雾剂 · No verified English nameCXHS2400083 | Yin Gu Pharmaceutical Co., Ltd. romanized |
| 2024/08/24New drug · Class 2.4 | 苯环喹溴铵鼻喷雾剂 · No verified English nameCXHS2400082 | Yin Gu Pharmaceutical Co., Ltd. romanized |
| 2024/08/24New drug · Class 1 | HYP-6589片 · No verified English nameCXHL2400863 | Name not romanized |
| 2024/08/24New drug · Class 1 | HYP-6589片 · No verified English nameCXHL2400862 | Name not romanized |
| 2024/08/24New drug · Class 2.2 | 醋酸地非法林片 · No verified English nameCXHL2400861 | Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/24New drug · Class 2.2 | 醋酸地非法林片 · No verified English nameCXHL2400860 | Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/24New drug · Class 2.2 | 醋酸地非法林片 · No verified English nameCXHL2400859 | Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/23Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400153 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/23Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400152 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/23Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400151 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/23Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2400150 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/08/23Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2402759 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/08/23Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402756 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/08/23Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402755 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/08/23Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2402754 | Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Tang Shan) Biopharmaceutical Co., Ltd. romanized |
| 2024/08/23Generic · Class 3 | 水合氯醛灌肠剂 · No verified English nameCYHS2402753 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2024/08/23Generic · Class 3 | Lidocaine Hydrochloride Ophthalmic GelCYHL2400175 | Shenyang Xing Qi Yan Yao Co., Ltd. romanized |
| 2024/08/23Generic · Class 3 | Epinastine Hydrochloride Eye DropsCYHL2400174 | Bai Shan Technology (Hu Zhou) Co., Ltd. romanized |
| 2024/08/23Generic · Class 3 | Ranolazine Prolonged-Release TabletsCYHL2400173 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2024/08/23Generic · Class 3 | Ranolazine Prolonged-Release TabletsCYHL2400172 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2024/08/23New drug · Class 1.1 | 糖宁通络片 · No verified English nameCXZL2400047 | Bai Ling Yu Xiu (Zhuhai) Pharmaceuticals Co., Ltd. romanized |
| 2024/08/23New drug · Class 1 | CM512注射液 · No verified English nameCXSL2400560 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2024/08/23New drug · Class 2.2 | 左乙拉西坦缓释颗粒 · No verified English nameCXHS2400081 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/08/23New drug · Class 2.2 | BCM899颗粒 · No verified English nameCXHL2400858 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/08/23New drug · Class 2.2 | BCM899颗粒 · No verified English nameCXHL2400857 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2024/08/22Generic · Class 3 | Calcium Gluconate InjectionCYHS2402745 | Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
47 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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