YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 306 drug applications between 15 December 2025 and 21 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 54, covering 35 drug names.
2025/12/15 – 2025/12/21
- New acceptances this week
- 306
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 71
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
306filings, 54 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 177 |
| New drug | 62 |
| Generic | 54 |
| Import | 5 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 152 |
| TCM | 100 |
| Therapeutic biologic | 52 |
| 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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mirogabalin Besilate Tablets | 4 | 1 | 61 |
| 2 | Finerenone Tablets | 3 | 2 | 69 |
| 3 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 4 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 5 | Nystatin Oral Suspension | 2 | 2 | 3 |
| 6 | Divalproex Sodium Extended-Release Tablets | 2 | 1 | 0 |
| 7 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 8 | Losartan Potassium Tablets | 2 | 1 | 5 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | Safinamide Methansulfonate Tablets | 2 | 1 | 20 |
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
177 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng De Shang Pharma Co., Ltd. romanized | 23 | 22 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 9 | 9 | 0 |
| 3 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 8 | 3 | 0 |
| 4 | Novo Nordisk A/S | 8 | 2 | 0 |
| 5 | Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized | 6 | 4 | 0 |
| 6 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Beijing Lian Er Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Pfizer Inc. | 4 | 2 | 0 |
| 10 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/19Import · Class 1 | 人源化抗BTN1A1单克隆抗体 · No verified English nameJXSL2500242 | STCube Inc.; Beijing Wei Li Fang Biotechnology Co. Ltd. |
| 2025/12/19Generic · Class 3 | 盐酸昂丹司琼口服溶液 · No verified English nameCYHS2504316 | Hainan Yuan Ying Pharmaceuticals Technology Co., Ltd. romanized; Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized |
| 2025/12/19New drug · Class 1.1 | GPN01020胶囊 · No verified English nameCXZL2500132 | Yuan Da Bei Lin (Xian) Pharma Co., Ltd. romanized; En Shi Tu Jia Zu Miao Zu Zi Zhi Zhou Center Hospital romanized |
| 2025/12/19New drug · Class 1.1 | 益肺散结丸 · No verified English nameCXZL2500131 | Guangzhou Zhong Pharmaceuticals University Di Yi Fu Shu Hospital romanized |
| 2025/12/19New drug · Class 1 | 维拉西塔单抗注射液 · No verified English nameCXSS2500142 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 注射用BL-M11D1 · No verified English nameCXSL2501099 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2501098 | Jiangsu Pu Rui Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2501097 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | SHR-1905注射液 · No verified English nameCXSL2501096 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/12/19New drug · Class 3.3 | SYS6053 · No verified English nameCXSL2501095 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | JMT206注射液 · No verified English nameCXSL2501094 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 注射用DR30206 · No verified English nameCXSL2501093 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 注射用IMM0306S · No verified English nameCXSL2501092 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 注射用HLX87 · No verified English nameCXSL2501091 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 替恩戈替尼片 · No verified English nameCXHS2500160 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 替恩戈替尼片 · No verified English nameCXHS2500159 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | 替恩戈替尼片 · No verified English nameCXHS2500158 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | QLS1410片 · No verified English nameCXHL2501421 | Qilu Pharmaceutical Co., Ltd. |
| 2025/12/19New drug · Class 1 | QLS1410片 · No verified English nameCXHL2501420 | Qilu Pharmaceutical Co., Ltd. |
| 2025/12/19New drug · Class 1 | 注射用PTT-936 · No verified English nameCXHL2501413 | Beijing Yan Ming Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501412 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501411 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501410 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | Sonrotoclax薄膜包衣片 · No verified English nameCXHL2501409 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | RP-0172胶囊 · No verified English nameCXHL2501406 | Li Bo (Shenzhen) Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | RP-0172胶囊 · No verified English nameCXHL2501405 | Li Bo (Shenzhen) Bio Technology Co., Ltd. romanized |
| 2025/12/19New drug · Class 1 | RP-0172胶囊 · No verified English nameCXHL2501404 | Li Bo (Shenzhen) Bio Technology Co., Ltd. romanized |
| 2025/12/18Import · Class 2.2 | TAK-755 · No verified English nameJXSL2500241 | Takeda Development Center Americas Inc. |
| 2025/12/18Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2504308 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized |
| 2025/12/18Generic · Class 3 | Colistimethate Sodium for InjectionCYHL2500225 | Tianjin Hong Ri Pharma Co., Ltd. romanized |
50 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.