YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 425 drug applications between 9 August 2024 and 15 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 133, covering 82 drug names.
2024/08/09 – 2024/08/15
- New acceptances this week
- 425
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- Accepted this week, now under review
- 3
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
425filings, 133 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 133 |
| New drug | 77 |
| Import re-registration | 11 |
| Import | 8 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 303 |
| TCM | 62 |
| Therapeutic biologic | 45 |
| Prophylactic biologic | 13 |
| 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
82 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 生理氯化钠溶液 · No verified English name | 5 | 1 | 17 |
| 2 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 4 | 4 | 9 |
| 3 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 4 | Ketorolac Tromethamine Injection | 4 | 2 | 4 |
| 5 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 6 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 3 | 1 | 14 |
| 7 | 甲磺酸多沙唑嗪片 · No verified English name | 3 | 1 | 0 |
| 8 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 9 | Labetalol Hydrochloride Injection | 3 | 1 | 4 |
| 10 | Ibrutinib Capsules | 2 | 2 | 9 |
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
243 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 2 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 6 | 4 | 0 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 4 | 0 |
| 5 | Henan Hua Feng Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 4 |
| 9 | Takeda Manufacturing Austria AG | 5 | 2 | 0 |
| 10 | Hebei Dao En Pharma Co., Ltd. romanized | 5 | 1 | 5 |
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
143 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/15Generic · Class 3 | Epalrestat TabletsCYHS2402661 | Beijing Sheng Yong Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanized |
| 2024/08/15Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2402658 | Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. |
| 2024/08/15Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2402656 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2024/08/15Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2402653 | Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Xin Shi Ji Pharma Co., Ltd. romanized |
| 2024/08/15Generic · Class 3 | 甲磺酸多沙唑嗪片 · No verified English nameCYHS2402650 | An Ruo Wei Ta Pharma Tai Zhou Co., Ltd. romanized |
| 2024/08/15Generic · Class 3 | 甲磺酸多沙唑嗪片 · No verified English nameCYHS2402649 | An Ruo Wei Ta Pharma Tai Zhou Co., Ltd. romanized |
| 2024/08/15Generic · Class 3 | 甲磺酸多沙唑嗪片 · No verified English nameCYHS2402648 | An Ruo Wei Ta Pharma Tai Zhou Co., Ltd. romanized |
| 2024/08/15Generic · Class 3 | Epalrestat TabletsCYHS2402647 | Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized |
| 2024/08/15New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2400543 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/08/15New drug · Class 1 | RC198注射液 · No verified English nameCXSL2400542 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/08/15New drug · Class 2.2 | DT-PR2215 · No verified English nameCXHL2400837 | Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/15New drug · Class 2.2 | DT-PR2215 · No verified English nameCXHL2400836 | Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/15New drug · Class 2.2 | DT-PR2215 · No verified English nameCXHL2400835 | Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/15New drug · Class 1 | ARD-885片 · No verified English nameCXHL2400834 | Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized |
| 2024/08/15New drug · Class 1 | ARD-885片 · No verified English nameCXHL2400833 | Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized |
| 2024/08/15New drug · Class 1 | NTB-3119M片 · No verified English nameCXHL2400832 | Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized |
| 2024/08/14Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2402644 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/08/14Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2402643 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/08/14Generic · Class 3 | Furosemide InjectionCYHS2402642 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2024/08/14Generic · Class 3 | Carbazochrome Sodium Sulfonate InjectionCYHS2402638 | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2024/08/14Generic · Class 3 | Progesterone InjectionCYHS2402629 | Anhui Chang Jiang Pharma Co., Ltd. romanized |
| 2024/08/14Generic · Class 3 | Pioglitazone and Metformin Hydrochloride TabletsCYHS2402628 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2024/08/14Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402625 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2024/08/14Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402624 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | XKH001注射液 · No verified English nameCXSL2400541 | Zhejiang Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized; Beijing Xin Kang He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | JCXH-211注射液 · No verified English nameCXSL2400540 | Jia Chen Xi Hai (Hangzhou) Bio Technology Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400831 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400830 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400829 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2400828 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
113 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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