YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 307 drug applications between 30 October 2025 and 5 November 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 41 drug names.
2025/10/30 – 2025/11/05
- New acceptances this week
- 307
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- Accepted this week, now under review
- 64
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
307filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 179 |
| Generic | 44 |
| New drug | 41 |
| Import | 15 |
| Unspecified | 14 |
| Import re-registration | 14 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 186 |
| TCM | 78 |
| Therapeutic biologic | 31 |
| Biologic | 10 |
| Prophylactic biologic | 2 |
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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢曲松钠/氯化钠注射液 · No verified English name | 2 | 1 | 3 |
| 2 | Minoxidil Liniment | 2 | 1 | 52 |
| 3 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 1 | 12 |
| 4 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 1 | 1 | 7 |
| 5 | Upadacitinib Sustained-release Tablets | 1 | 1 | 43 |
| 6 | Acetylcysteine Injection | 1 | 1 | 53 |
| 7 | Tafluprost Eye Drops | 1 | 1 | 3 |
| 8 | Pemafibrate Tablets | 1 | 1 | 23 |
| 9 | Crisaborole Ointment | 1 | 1 | 26 |
| 10 | Carbidopa and Levodopa Sustained-release Tablets | 1 | 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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Bao Long Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 2 | Bayer Vital GmbH | 5 | 2 | 0 |
| 3 | Eisai Co. Ltd. | 5 | 1 | 0 |
| 4 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 6 | Sanofi Winthrop Industrie | 4 | 2 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Biogen Netherlands B.V. | 4 | 1 | 0 |
| 9 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 10 | GUERBET | 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
72 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/05Import · Class 2.2 | 注射用德曲妥珠单抗 · No verified English nameJXSS2500136 | Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2025/11/05Import · Class 1 | BIIB115注射液 · No verified English nameJXHL2500343 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2025/11/05Import · Class 1 | E2086 · No verified English nameJXHL2500342 | Eisai Co. Ltd.; Eisai China Inc. |
| 2025/11/05Import · Class 1 | E2086 · No verified English nameJXHL2500341 | Eisai Co. Ltd.; Eisai China Inc. |
| 2025/11/05Import · Class 1 | E2086 · No verified English nameJXHL2500340 | Eisai Co. Ltd.; Eisai China Inc. |
| 2025/11/05Import · Class 1 | E2086 · No verified English nameJXHL2500339 | Eisai Co. Ltd.; Eisai China Inc. |
| 2025/11/05Import · Class 1 | E2086 · No verified English nameJXHL2500338 | Eisai Co. Ltd.; Eisai China Inc. |
| 2025/11/05Import · Class 1 | SAR443122 硬胶囊 · No verified English nameJXHL2500337 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/11/05Generic · Class 3 | Minoxidil LinimentCYHS2503869 | Jiangsu Xi Er Sheng Pharma Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/11/05Generic · Class 3 | Minoxidil LinimentCYHS2503868 | Jiangsu Xi Er Sheng Pharma Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/11/05Generic · Class 3 | Benazepril Hydrochloride and Hydrochlorothiazide TabletsCYHS2503864 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/11/05Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2503862 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/11/05Generic · Class 3 | Bilastine Oral SolutionCYHS2503861 | Sichuan Sen Ke Pharmaceutical Co., Ltd. romanized |
| 2025/11/05New drug · Class 3.3 | 注射用曲妥珠单抗 · No verified English nameCXSS2500118 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2025/11/05New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2500944 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/11/05New drug · Class 1 | 宫血间充质干细胞注射液 · No verified English nameCXSL2500943 | Zhejiang Sheng Chuang Jing Zhun Medical Technology Co., Ltd. romanized |
| 2025/11/05New drug · Class 1 | TRC003注射液 · No verified English nameCXHL2501210 | Tong Rui Biopharmaceutical (Chengdu) Co., Ltd. romanized |
| 2025/11/05New drug · Class 1 | VV913胶囊 · No verified English nameCXHL2501209 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/05New drug · Class 1 | VV913胶囊 · No verified English nameCXHL2501208 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/05New drug · Class 1 | VV913胶囊 · No verified English nameCXHL2501207 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/05New drug · Class 1 | 伊匹乌肽散剂 · No verified English nameCXHL2501206 | Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized |
| 2025/11/04Import · Class 2.4 | 镥[177Lu] 特昔维匹肽注射液 · No verified English nameJXHS2500125 | Novartis Pharma Schweiz AG; Advanced Accelerator Applications (Italy) S.R.L.; Beijing Novartis Pharma Co. Ltd. |
| 2025/11/04Generic · Class 3 | Furosemide Oral SolutionCYHS2503859 | Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2025/11/04Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2503856 | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized; Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/04Generic · Class 3 | 氟[1?F]贝他苯注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2503855 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized; Jiangsu Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized; Beijing Shan Wei Zheng Zi Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2500942 | Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | 自体NK细胞注射液 · No verified English nameCXSL2500941 | Guangxi Tai Mei Ren Sheng Bio Technology Co., Ltd. romanized |
| 2025/11/04New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSL2500940 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2500939 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/11/04New drug · Class 1 | IMM2510 · No verified English nameCXSL2500938 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
42 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.