YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 414 drug applications between 7 December 2024 and 13 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 115, covering 79 drug names.
2024/12/07 – 2024/12/13
- New acceptances this week
- 414
- Drugs with new generic filings (by drug name, de-duplicated)
- 79
- Accepted this week, now under review
- 5
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
414filings, 115 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 189 |
| Generic | 115 |
| New drug | 77 |
| Import | 19 |
| Unspecified | 10 |
| Import re-registration | 3 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 277 |
| TCM | 72 |
| Therapeutic biologic | 49 |
| Biologic | 8 |
| Prophylactic biologic | 7 |
| In vitro diagnostic reagent | 1 |
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
79 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 14 | 7 | 60 |
| 2 | Ambroxol Hydrochloride Oral Solution | 5 | 1 | 46 |
| 3 | Empagliflozin Tablets | 4 | 2 | 18 |
| 4 | Isavuconazonium Sulfate for Injection | 3 | 3 | 15 |
| 5 | 醋酸兰瑞肽缓释注射液(预充式) · No verified English name | 3 | 1 | 0 |
| 6 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 7 | Mupirocin Ointment | 2 | 2 | 30 |
| 8 | Voriconazole Tablets | 2 | 1 | 1 |
| 9 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 10 | 利伐沙班口崩片 · No verified English name | 2 | 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
274 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Novo Nordisk A/S | 9 | 2 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 9 | 2 | 0 |
| 3 | Ya Bao Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 5 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Tong Hua Zheng Yuan Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 2 |
| 8 | Jiangxi Qing Feng Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Hainan Sai Li Ke Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Merck Sharp & Dohme B. V. | 4 | 1 | 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
130 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/13Generic · Class 3 | 咪达唑仑口服溶液 · No verified English nameCYHS2404337 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2024/12/13Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2404336 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2024/12/13Generic · Class 3 | Nafamostat Mesilate for InjectionCYHL2400257 | Kang Pu Pharma Co., Ltd. romanized |
| 2024/12/13Generic · Class 3 | 双氯芬酸依泊胺贴 · No verified English nameCYHL2400256 | Sichuan Tian Dao Pharmaceutical Co., Ltd. romanized |
| 2024/12/13New drug · Class 1.1 | 醒脑益智胶囊 · No verified English nameCXZL2400090 | Tang Ning Pharmaceuticals Technology (Jinan) Co., Ltd. romanized |
| 2024/12/13New drug · Class 1 | YFQLXB-UC01注射液 · No verified English nameCXSL2400857 | Shandong Sheng Qi Lu Xi Bao Zhi Liao Gong Cheng Technology Co., Ltd. romanized |
| 2024/12/13New drug · Class 1 | BN-1001眼用注射液 · No verified English nameCXSL2400856 | Nanjing Bei Si Ao Bio Technology Co., Ltd. romanized |
| 2024/12/13New drug · Class 1 | BN-1001眼用注射液 · No verified English nameCXSL2400855 | Nanjing Bei Si Ao Bio Technology Co., Ltd. romanized |
| 2024/12/13New drug · Class 1 | PH-501片 · No verified English nameCXHL2401372 | Yuan Yan Gang (Shanghai) Pharmaceuticals Co., Ltd. romanized; Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized |
| 2024/12/13New drug · Class 1 | XS-03片 · No verified English nameCXHL2401371 | Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized |
| 2024/12/13New drug · Class 1 | XS-03片 · No verified English nameCXHL2401370 | Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized |
| 2024/12/13New drug · Class 1 | XS-03片 · No verified English nameCXHL2401369 | Jiangsu Xing Sheng Xin Hui Pharmaceuticals Co., Ltd. romanized |
| 2024/12/12Import · Class 1 | 注射用M9140 · No verified English nameJXSL2400236 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2024/12/12Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2400291 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/12Import · Class 1 | Baxdrostat片 · No verified English nameJXHL2400290 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/12Import · Class 1 | Olomorasib胶囊 · No verified English nameJXHL2400289 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/12Import · Class 1 | Olomorasib胶囊 · No verified English nameJXHL2400288 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2024/12/12Import · Class 1 | Sepantronium Bromide注射液 · No verified English nameJXHL2400287 | Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd. |
| 2024/12/12Generic · Class 3 | Bumetanide InjectionCYHS2404331 | Xu Bi Di Pharma (Cang Zhou) Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | Peramivir InjectionCYHS2404329 | Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/12/12Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2404328 | Beijing Foyou Pharma CO.,LTD |
| 2024/12/12Generic · Class 3 | 利伐沙班口崩片 · No verified English nameCYHS2404327 | Beijing Foyou Pharma CO.,LTD |
| 2024/12/12Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2404325 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | 昂丹司琼口溶膜 · No verified English nameCYHS2404324 | Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2404322 | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | Propranolol Hydrochloride TabletsCYHS2404319 | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2404316 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2404314 | Hua Run Shuang He Pharma Co., Ltd. romanized; Hua Run Zi Zhu Pharma Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2404313 | Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2024/12/12Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2404312 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
100 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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