YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 388 drug applications between 6 November 2025 and 12 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 49 drug names.
2025/11/06 – 2025/11/12
- New acceptances this week
- 388
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 83
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
388filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| Generic | 70 |
| New drug | 66 |
| Import | 22 |
| Import re-registration | 20 |
| Unspecified | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 221 |
| TCM | 99 |
| Therapeutic biologic | 58 |
| Prophylactic biologic | 6 |
| Biologic | 4 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefditoren Pivoxil Granules | 4 | 2 | 18 |
| 2 | Finerenone Tablets | 3 | 2 | 69 |
| 3 | 奥氮平萨米多芬片 · No verified English name | 3 | 1 | 0 |
| 4 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 5 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 6 | 利伐沙班干混悬剂 · No verified English name | 2 | 1 | 2 |
| 7 | Carboplatin Injection | 2 | 1 | 10 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Lamotrigine Dispersible Tablets | 2 | 1 | 2 |
| 10 | 氯化钾氯化钠注射液 · 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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Shu Zhong Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 3 | Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | AstraZeneca AB | 6 | 5 | 0 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 6 | 2 | 0 |
| 7 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 8 | Bayer AG | 5 | 4 | 0 |
| 9 | Takeda Development Center Americas Inc. | 5 | 2 | 0 |
| 10 | Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized | 5 | 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 |
|---|---|---|
| 2025/11/12Generic · Class 3 | Idarubicin Hydrochloride InjectionCYHS2503934 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2503933 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2503932 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | Potassium Aspartate And Magnesium Aspartate InjectionCYHS2503931 | Suzhou Te Rui Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2503930 | Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | Hydrocortisone Sodium Succinate for InjectionCYHS2503929 | Hainan Brilliant Pharmaceutical Co., Ltd.; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2503928 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2025/11/12Generic · Class 3 | Fosphenytoin Sodium InjectionCYHS2503927 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2025/11/12Generic · Class 3 | 聚乙二醇4000散(儿童型) · No verified English nameCYHS2503926 | Ao Nuo (Zhongguo) Pharmaceutical Co., Ltd. romanized; Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2503923 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | 奥氮平萨米多芬片 · No verified English nameCYHL2500202 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | 奥氮平萨米多芬片 · No verified English nameCYHL2500201 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/12Generic · Class 3 | 奥氮平萨米多芬片 · No verified English nameCYHL2500200 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/11/12New drug · Class 1.1 | 运脾化痰通窍颗粒 · No verified English nameCXZL2500111 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/11/12New drug · Class 2.2 | 黄龙咳喘颗粒 · No verified English nameCXZL2500110 | Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized |
| 2025/11/12New drug · Class 1 | 注射用HDM2005 · No verified English nameCXSL2500964 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2025/11/12New drug · Class 1 | QLS7305注射液 · No verified English nameCXHL2501250 | Qilu Pharmaceutical Co., Ltd. |
| 2025/11/12New drug · Class 1 | QLS7305注射液 · No verified English nameCXHL2501249 | Qilu Pharmaceutical Co., Ltd. |
| 2025/11/12New drug · Class 2.4 | 玛仕度肽注射液 · No verified English nameCXHL2501245 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/12New drug · Class 2.4 | 玛仕度肽注射液 · No verified English nameCXHL2501244 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/12New drug · Class 2.4 | 玛仕度肽注射液 · No verified English nameCXHL2501243 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/12New drug · Class 2.4 | 玛仕度肽注射液 · No verified English nameCXHL2501242 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/11/12New drug · Class 2.3 | LH-2417片 · No verified English nameCXHL2501241 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2025/11/12New drug · Class 2.3 | LH-2417片 · No verified English nameCXHL2501240 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2025/11/12New drug · Class 2.3 | LH-2417片 · No verified English nameCXHL2501239 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2025/11/12New drug · Class 2.3 | 多替拉韦拉米夫定替诺福韦片 · No verified English nameCXHL2501238 | Jiangsu Ai Di Pharma Group Co., Ltd. romanized |
| 2025/11/12New drug · Class 1 | ZL-65片 · No verified English nameCXHL2501237 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/12New drug · Class 1 | ZL-65片 · No verified English nameCXHL2501236 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/12New drug · Class 1 | ZL-65片 · No verified English nameCXHL2501234 | Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/12New drug · Class 2.2; 2.4 | CZ012凝胶 · No verified English nameCXHL2501233 | Zhejiang Cui Ze Biopharmaceuticals 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.