YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 423 drug applications between 8 August 2024 and 14 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 135, covering 82 drug names.
2024/08/08 – 2024/08/14
- New acceptances this week
- 423
- Drugs with new generic filings (by drug name, de-duplicated)
- 82
- 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
423filings, 135 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 176 |
| Generic | 135 |
| New drug | 73 |
| Unspecified | 18 |
| Import re-registration | 13 |
| Import | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 299 |
| TCM | 53 |
| Therapeutic biologic | 49 |
| Prophylactic biologic | 12 |
| Biologic | 10 |
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 | Dapoxetine Hydrochloride Tablets | 4 | 2 | 20 |
| 3 | 苯磺酸左氨氯地平片 · No verified English name | 4 | 2 | 45 |
| 4 | Ketorolac Tromethamine Injection | 4 | 2 | 4 |
| 5 | Pioglitazone and Metformin Hydrochloride Tablets | 3 | 3 | 10 |
| 6 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 3 | 3 | 9 |
| 7 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 8 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 3 | 1 | 14 |
| 9 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 10 | Labetalol Hydrochloride Injection | 3 | 1 | 4 |
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
239 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 2 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Novo Nordisk A/S | 7 | 3 | 0 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 6 | 4 | 0 |
| 7 | Henan Hua Feng Pharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Pfizer Inc. | 5 | 4 | 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
139 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/08/14New drug · Class 1 | LPM682000012片 · No verified English nameCXHL2400827 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | LPM682000012片 · No verified English nameCXHL2400826 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/08/14New drug · Class 1 | LPM682000012片 · No verified English nameCXHL2400825 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Import · Class 1 | 马塔西单抗注射液 · No verified English nameJXSS2400065 | Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd. |
| 2024/08/13Import · Class 1 | CID-103注射液 · No verified English nameJXSL2400148 | CASI Pharmaceuticals Inc.; CASI Pharmaceuticals (China) Co. Ltd. |
| 2024/08/13Import · Class 2.4 | 盐酸奎扎替尼片 · No verified English nameJXHL2400200 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/08/13Import · Class 2.4 | 盐酸奎扎替尼片 · No verified English nameJXHL2400199 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2024/08/13Generic · Class 3 | Potassium Chloride InjectionCYHS2402622 | Xu Bi Di Pharma (Hebei) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2402621 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2402620 | Chongqing Shi Li De Pharmaceuticals Technology Co., Ltd. romanized; Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Diflunisal TabletsCYHS2402617 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2402610 | Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/08/13Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2402609 | Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/08/13Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2402606 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2402605 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/08/13Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402604 | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
109 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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