YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 356 drug applications between 2 November 2024 and 8 November 2024 (data as of 14 November 2026 06:00). Of these, generic applications numbered 97, covering 72 drug names.
2024/11/02 – 2024/11/08
- New acceptances this week
- 356
- Drugs with new generic filings (by drug name, de-duplicated)
- 72
- 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
356filings, 97 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 97 |
| New drug | 65 |
| Import | 17 |
| Import re-registration | 15 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 273 |
| TCM | 49 |
| Therapeutic biologic | 28 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 1 |
| Biologic | 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
72 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 58 |
| 2 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 4 | 2 | 23 |
| 3 | Methotrexate Injection | 3 | 2 | 11 |
| 4 | Repaglinide Tablets | 3 | 1 | 6 |
| 5 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 6 | Piracetam Injection | 2 | 1 | 9 |
| 7 | Doxofylline Tablets | 2 | 1 | 2 |
| 8 | 布比卡因脂质体注射液 · No verified English name | 2 | 1 | 7 |
| 9 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 10 | Ursodeoxycholic acid oral suspension | 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
207 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangdong Sunho Pharmaceutical Co., Ltd. | 20 | 12 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Qilu Pharmaceutical Co., Ltd. | 6 | 3 | 1 |
| 6 | GE Healthcare AS | 6 | 1 | 0 |
| 7 | Teva Neuroscience Inc. | 6 | 1 | 0 |
| 8 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Ya Bao Pharma Group Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | AstraZeneca AB | 4 | 2 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/08Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2403823 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Jiu Quan Da De Li Pharmaceutical Co., Ltd. romanized |
| 2024/11/08New drug · Class 1.1 | 苓仙颗粒 · No verified English nameCXZL2400077 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | IBI3010 · No verified English nameCXSL2400758 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | 注射用SIBP-A19 · No verified English nameCXSL2400757 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | RGL-2201注射液 · No verified English nameCXSL2400756 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | 注射用YK012 · No verified English nameCXSL2400755 | Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2024/11/08New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSL2400754 | Qilu Pharmaceutical Co., Ltd. |
| 2024/11/08New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSL2400753 | Qilu Pharmaceutical Co., Ltd. |
| 2024/11/08New drug · Class 1.2 | 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400752 | Da Mian Yi Miao (Guangzhou) Co., Ltd. romanized; Hua Lan Bio Yi Miao Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | ASN-3186胶囊 · No verified English nameCXHL2401204 | Shanghai Ya Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/08New drug · Class 2.2 | HXHTT024 · No verified English nameCXHL2401203 | Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | HS-10518胶囊 · No verified English nameCXHL2401202 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | HS-10518胶囊 · No verified English nameCXHL2401201 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | HS-10518胶囊 · No verified English nameCXHL2401200 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/08New drug · Class 1 | NTQ5082胶囊 · No verified English nameCXHL2401199 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2024/11/08New drug · Class 1 | NTQ5082胶囊 · No verified English nameCXHL2401198 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2024/11/07Import · Class 3.1 | 艾可瑞妥单抗注射液 · No verified English nameJXSS2400101 | AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2024/11/07Import · Class 2.4 | Vorasidenib片 · No verified English nameJXHL2400266 | Institut de Recherches Internationales Servier |
| 2024/11/07Import · Class 2.4 | Vorasidenib片 · No verified English nameJXHL2400265 | Institut de Recherches Internationales Servier |
| 2024/11/07Generic · Class 3 | Piracetam InjectionCYHS2403809 | Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | Piracetam InjectionCYHS2403808 | Jia Heng (Zhuhai Heng Qin) Pharmaceuticals Technology Co., Ltd. romanized; Henan Fu Sen Pharma Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2403802 | Hebei Zhi Heng Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403801 | Shandong Long Yang Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403800 | Shandong Long Yang Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jia Heng Pharmaceutical Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | Magnesium Sulfate InjectionCYHS2403798 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | Magnesium Sulfate InjectionCYHS2403797 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2403794 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | 布比卡因脂质体注射液 · No verified English nameCYHS2403793 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/11/07Generic · Class 3 | Drotaverine Hydrochloride TabletsCYHS2403792 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/11/07Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2403788 | Hainan Ru Kang Bio Technology Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
84 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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