YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 353 drug applications between 31 October 2025 and 6 November 2025 (data as of 14 November 2026 06:00). Of these, generic applications numbered 61, covering 52 drug names.
2025/10/31 – 2025/11/06
- New acceptances this week
- 353
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 87
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
353filings, 61 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 200 |
| Generic | 61 |
| New drug | 42 |
| Import re-registration | 18 |
| Import | 17 |
| Unspecified | 15 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 210 |
| TCM | 94 |
| Therapeutic biologic | 35 |
| Biologic | 10 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 2 | Vonoprazan Fumarate Tablets | 2 | 1 | 58 |
| 3 | 氯化钾氯化钠注射液 · No verified English name | 2 | 1 | 4 |
| 4 | 注射用头孢曲松钠/氯化钠注射液 · No verified English name | 2 | 1 | 3 |
| 5 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 6 | Minoxidil Liniment | 2 | 1 | 52 |
| 7 | 苯磺酸氨氯地平口崩片 · No verified English name | 2 | 1 | 2 |
| 8 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 2 | 1 | 12 |
| 9 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 10 | Scopolamine Butylbromide Injection | 1 | 1 | 7 |
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
225 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 2 | 0 |
| 2 | Bao Long Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Bayer Vital GmbH | 5 | 2 | 0 |
| 5 | Eisai Co. Ltd. | 5 | 1 | 0 |
| 6 | Chongqing Ke Rui Nan Hai Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Sanofi Winthrop Industrie | 4 | 2 | 0 |
| 8 | Shanghai He Huang Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Biogen Netherlands B.V. | 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/11/06Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2500138 | Merck Sharp & Dohme LLC; 1. MSD Ireland (Carlow); 2. Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2025/11/06Import · Class 3.1 | 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2500137 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd. |
| 2025/11/06Import · Class 1 | AZD5492 · No verified English nameJXSL2500210 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/11/06Import · Class 1 | SAR445399 · No verified English nameJXSL2500209 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/11/06Generic · Class 3 | Indobufen TabletsCYHS2503889 | Hunan Zheng Qing Pharmaceutical Group Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized |
| 2025/11/06Generic · Class 3 | 辅酶Q10片 · No verified English nameCYHS2503886 | Anhui Tai Du Biopharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/11/06Generic · Class 3 | 苯磺酸氨氯地平口崩片 · No verified English nameCYHS2503884 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/11/06Generic · Class 3 | 苯磺酸氨氯地平口崩片 · No verified English nameCYHS2503883 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/11/06Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2503876 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2025/11/06Generic · Class 3 | Ketoprofen PatchesCYHL2500196 | Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized |
| 2025/11/06New drug · Class 1.1 | 车前子片 · No verified English nameCXZL2500108 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized |
| 2025/11/06New drug · Class 1 | 注射用QL2401 · No verified English nameCXSL2500949 | Qilu Pharmaceutical Co., Ltd. |
| 2025/11/06New drug · Class 1 | 注射用YL205 · No verified English nameCXSL2500948 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | SYS6055注射液 · No verified English nameCXSL2500947 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized |
| 2025/11/06New drug · Class 1.2 | 冻干鼻喷流感减毒活疫苗 · No verified English nameCXSL2500946 | Di Fu Run Si (Hefei) Bio Technology Co., Ltd. romanized; Zhejiang Di Fu Run Si Bio Technology Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | RGB-5088胰岛细胞注射液 · No verified English nameCXSL2500945 | Hangzhou Rui Pu Chen Chuang Technology Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2501216 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2501215 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | HRS-7535片 · No verified English nameCXHL2501214 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | HS-10383-B片 · No verified English nameCXHL2501213 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | HS-10383-B片 · No verified English nameCXHL2501212 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/11/06New drug · Class 1 | HS-10383-B片 · No verified English nameCXHL2501211 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 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. |
51 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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