YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 379 drug applications between 7 November 2025 and 13 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 49 drug names.
2025/11/07 – 2025/11/13
- New acceptances this week
- 379
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- Accepted this week, now under review
- 74
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
379filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 204 |
| Generic | 68 |
| New drug | 60 |
| Import | 26 |
| Import re-registration | 13 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 222 |
| TCM | 99 |
| Therapeutic biologic | 50 |
| Biologic | 4 |
| Prophylactic 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 | Finerenone Tablets | 3 | 2 | 69 |
| 2 | 奥氮平萨米多芬片 · No verified English name | 3 | 1 | 0 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 5 | Iguratimod Tablets | 2 | 2 | 23 |
| 6 | Acetylcysteine Oral Solution | 2 | 1 | 11 |
| 7 | 利伐沙班干混悬剂 · No verified English name | 2 | 1 | 2 |
| 8 | Carboplatin Injection | 2 | 1 | 10 |
| 9 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 10 | Lamotrigine Dispersible Tablets | 2 | 1 | 2 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Takeda Development Center Americas Inc. | 8 | 3 | 0 |
| 2 | Sichuan Shu Zhong Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 7 | 3 | 0 |
| 5 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 6 | Qinghai Chun Tian Yao Yong Zi Yuan Technology Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Bracco Imaging S.P.A. | 6 | 1 | 0 |
| 9 | AstraZeneca AB | 5 | 4 | 0 |
| 10 | Pfizer Inc. | 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
109 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/13Import · Class 2.2 | 多奈单抗注射液 · No verified English nameJXSL2500221 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2500131 | Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2500130 | Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2500129 | Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 2.4 | 替尔泊肽注射液 · No verified English nameJXHS2500128 | Eli Lilly Nederland B.V.; Eli Lilly Italia S.p.A.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/11/13Import · Class 1 | RO7795081 · No verified English nameJXHL2500352 | F. Hoffmann-La Roche Ltd.; Roche R&D Center (China) Ltd. |
| 2025/11/13Import · Class 1 | RO7795081 · No verified English nameJXHL2500351 | F. Hoffmann-La Roche Ltd.; Roche R&D Center (China) Ltd. |
| 2025/11/13Import · Class 1 | RO7795081 · No verified English nameJXHL2500350 | F. Hoffmann-La Roche Ltd.; Roche R&D Center (China) Ltd. |
| 2025/11/13Generic · Class 3 | Calcitriol Oral SolutionCYHS2503942 | Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2025/11/13Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2503937 | Hua Zhong Pharma Co., Ltd. romanized |
| 2025/11/13Generic · Class 3 | 雌二醇左炔诺孕酮贴片 · No verified English nameCYHL2500203 | Hunan Pai Ge Lan Pharma Co., Ltd. romanized |
| 2025/11/13New drug · Class 1.1 | 天丹定眩颗粒 · No verified English nameCXZL2500112 | Sichuan Sheng Xian Dai Zhong Yao Innovation Technology Co., Ltd. romanized; Chengdu Zhong Pharmaceuticals University romanized; Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2025/11/13New drug · Class 1 | CS01单抗注射液 · No verified English nameCXSL2500965 | Zhong Shan Heng Dong Biopharmaceutical Co., Ltd. romanized |
| 2025/11/13New drug · Class 1 | GH55胶囊 · No verified English nameCXHL2501251 | Qin Hao Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/11/13New drug · Class 1 | 羧胺三唑软胶囊 · No verified English nameCXHL2501248 | Guangdong Yin Zhu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/13New drug · Class 1 | 羧胺三唑软胶囊 · No verified English nameCXHL2501247 | Guangdong Yin Zhu Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/13New drug · Class 2.2 | 1H52A · No verified English nameCXHL2501246 | Pu Zhao Guo Kang (Hubei) Pharma Co., Ltd. romanized; Wen Tao Innovation Drug Research (Beijing) Co., Ltd. romanized |
| 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 |
79 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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