YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 379 drug applications between 29 August 2025 and 4 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 105, covering 78 drug names.
2025/08/29 – 2025/09/04
- New acceptances this week
- 379
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 111
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, 105 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 105 |
| New drug | 81 |
| Import | 24 |
| Unspecified | 8 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 258 |
| Therapeutic biologic | 58 |
| TCM | 54 |
| Biologic | 7 |
| 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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 2 | 70 |
| 2 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 3 | Ozagrel Sodium Injection | 3 | 1 | 3 |
| 4 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 5 | Rivaroxaban Tablets | 2 | 1 | 3 |
| 6 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 7 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English name | 2 | 1 | 1 |
| 8 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 9 | Flomoxef Sodium for Injection | 2 | 1 | 9 |
| 10 | 注射用氨苄西林钠舒巴坦钠/氯化钠注射液 · No verified English name | 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
221 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 9 | 1 | 0 |
| 3 | Gui Lin Hua Run Tian He Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Novo Nordisk A/S | 7 | 3 | 0 |
| 5 | Zhuhai Tong Yuan Pharma Co., Ltd. romanized | 6 | 3 | 2 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Eli Lilly and Company | 5 | 2 | 0 |
| 8 | Takeda Canada Inc | 5 | 1 | 0 |
| 9 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 10 | Hubei Ke Lun Pharma Co., Ltd. romanized | 5 | 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
139 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/04Import · Class 2.4 | 阿贝西利片 · No verified English nameJXHS2500094 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2025/09/04Import · Class 2.4 | Trametinib TabletsJXHS2500093 | Novartis Europharm Limited; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2025/09/04Import · Class 2.4 | Trametinib TabletsJXHS2500092 | Novartis Europharm Limited; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2025/09/04Import · Class 2.4 | BI 1810631 片 · No verified English nameJXHL2500256 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2025/09/04Import · Class 1 | Dexpramipexole片 · No verified English nameJXHL2500255 | Areteia Therapeutics Inc.; Parexel China Co Ltd. |
| 2025/09/04Generic · Class 3 | Pirarubicin Hydrochloride for InjectionCYHS2503252 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/09/04New drug · Class 1 | 注射用DB-1418 · No verified English nameCXSL2500764 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/09/04New drug · Class 1 | QM103细胞注射液 · No verified English nameCXSL2500762 | Beijing Qi Mai Yong Hua Bio Technology Co., Ltd. romanized |
| 2025/09/04New drug · Class 1 | HS_SW01 细胞注射液 · No verified English nameCXSL2500761 | Shenzhen Hui Shan Bio Technology Co., Ltd. romanized |
| 2025/09/04New drug · Class 1 | 注射用AN8025 · No verified English nameCXSL2500760 | Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/09/04New drug · Class 1 | 注射用LM-350 · No verified English nameCXSL2500759 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/09/03Import · Class 1 | LY4064809片 · No verified English nameJXHL2500254 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/03Import · Class 1 | LY4064809片 · No verified English nameJXHL2500253 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/03Generic · Class 3 | Diprophylline InjectionCYHS2503238 | Jilin Sheng Shuang Sheng Feng Pharma Co., Ltd. romanized |
| 2025/09/03New drug · Class 1.1 | 1301-01颗粒 · No verified English nameCXZL2500072 | Zhongguo Yao Ke University romanized |
| 2025/09/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500089 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2025/09/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500088 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2025/09/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500087 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2025/09/03New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2500086 | Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | QX027N注射液 · No verified English nameCXSL2500758 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | QX027N注射液 · No verified English nameCXSL2500757 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | 玛氘诺沙韦颗粒 · No verified English nameCXHS2500115 | Jia Xing An Di Kang Bio Technology Co., Ltd. romanized; Hainan Xian Sheng Pharma Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | BGM1812注射液 · No verified English nameCXHL2500946 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | HRS-8364片 · No verified English nameCXHL2500945 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | HRS-8364片 · No verified English nameCXHL2500944 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | SAL0139片 · No verified English nameCXHL2500943 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/09/03New drug · Class 1 | SAL0139片 · No verified English nameCXHL2500942 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2025/09/02Import · Class 1 | 斯贝利单抗注射液 · No verified English nameJXSS2500118 | Otsuka Pharmaceutical Co. Ltd.; Vetter Pharma-Fertigung GmbH & Co. KG; Otsuka Beijing Research Institute |
| 2025/09/02Import · Class 2.2 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500117 | AstraZeneca AB; Name not romanized |
| 2025/09/02Import · Class 2.2 | 本瑞利珠单抗注射液 · No verified English nameJXSS2500116 | AstraZeneca AB; Name not romanized |
109 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.