YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 422 drug applications between 12 December 2024 and 18 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 87 drug names.
2024/12/12 – 2024/12/18
- New acceptances this week
- 422
- Drugs with new generic filings (by drug name, de-duplicated)
- 87
- Accepted this week, now under review
- 4
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
422filings, 111 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 190 |
| Generic | 111 |
| New drug | 81 |
| Import | 27 |
| Unspecified | 7 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 272 |
| TCM | 87 |
| Therapeutic biologic | 53 |
| Biologic | 5 |
| 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
87 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride Oral Solution | 5 | 1 | 46 |
| 2 | Nafamostat Mesilate for Injection | 4 | 3 | 38 |
| 3 | 醋酸兰瑞肽缓释注射液(预充式) · No verified English name | 3 | 1 | 0 |
| 4 | 阿贝西利片 · No verified English name | 3 | 1 | 2 |
| 5 | Fusidic Acid Cream | 2 | 2 | 15 |
| 6 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 7 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 9 |
| 8 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
| 9 | 布比卡因脂质体注射液 · No verified English name | 2 | 1 | 7 |
| 10 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 2 | 1 | 12 |
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
269 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 12 | 10 | 0 |
| 2 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 9 | 2 | 0 |
| 3 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Novo Nordisk A/S | 6 | 2 | 0 |
| 5 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 5 | 1 | 5 |
| 8 | Jiangxi Cheng Zhi Yong Feng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 4 | 3 |
| 10 | Fu Yuan Pharma Co., Ltd. romanized | 4 | 4 | 1 |
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
147 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/18Import · Class 1 | AZD4360 · No verified English nameJXSL2400241 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/12/18Import · Class 2.4 | 硫酸瑞美吉泮口崩片 · No verified English nameJXHL2400296 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2024/12/18Import · Class 1 | KFA115 · No verified English nameJXHL2400295 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/12/18Import · Class 1 | KFA115 · No verified English nameJXHL2400294 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/12/18Import · Class 1 | KFA115 · No verified English nameJXHL2400293 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/12/18Import · Class 1 | KFA115 · No verified English nameJXHL2400292 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/12/18Generic · Class 3 | Procaterol Hydrochloride GranulesCYHS2404400 | Sichuan Da Zhong Pharmaceutical Co., Ltd. romanized |
| 2024/12/18Generic · Class 3 | Ursodeoxycholic Acid TabletsCYHS2404398 | Zhong Shan Bai Ling Bio Technology Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized |
| 2024/12/18Generic · Class 3 | 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2404396 | Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/18Generic · Class 3 | Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2404392 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2024/12/18Generic · Class 3 | 聚乙二醇4000散(儿童型) · No verified English nameCYHS2404390 | Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized |
| 2024/12/18Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2404387 | Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2024/12/18New drug · Class 1.1 | 仁术健胃颗粒 · No verified English nameCXZS2400037 | Nanjing Zhong Shan Pharmaceutical Co., Ltd. romanized |
| 2024/12/18New drug · Class 1.2 | 白头翁皂苷B4 · No verified English nameCXZL2400093 | Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized |
| 2024/12/18New drug · Class 1.2 | 白头翁皂苷B4栓 · No verified English nameCXZL2400092 | Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized |
| 2024/12/18New drug · Class 1 | MWN105注射液 · No verified English nameCXSL2400879 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2024/12/18New drug · Class 1 | 注射用PCNAT-01 · No verified English nameCXSL2400878 | An Da Bio Drug Kai Fa (Shenzhen) Co., Ltd. romanized |
| 2024/12/17Import · Class 1 | SAR402663注射液 · No verified English nameJXSL2400240 | Sanofi-Aventis Recherche & Développement; SANOFI (CHINA) INVESTMENT CO. LTD |
| 2024/12/17Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2404385 | Hubei Xin Ze Fei Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2404384 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/12/17Generic · Class 3 | Trimebutine Maleate TabletsCYHS2404381 | Zhejiang Nord Pharmaceutical Co., Ltd |
| 2024/12/17Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2404375 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2404373 | Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2404372 | Shandong Li Nuo Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2404371 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Epinephrine InjectionCYHS2404369 | Wuhan Jiu An Drug Research Institute Co., Ltd. romanized; Wuhan Jiu An Pharma Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2404368 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2404367 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Oxycodone And Acetaminophen TabletsCYHS2404364 | Beijing Hua Su Pharmaceutical Co., Ltd. romanized |
| 2024/12/17Generic · Class 3 | Terlipressin Acetate InjectionCYHS2404363 | Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized |
117 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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