YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 311 drug applications between 9 December 2025 and 15 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 58 drug names.
2025/12/09 – 2025/12/15
- New acceptances this week
- 311
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 96
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
311filings, 75 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 132 |
| Generic | 75 |
| New drug | 73 |
| Unspecified | 12 |
| Import re-registration | 12 |
| Import | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 192 |
| TCM | 68 |
| Therapeutic biologic | 37 |
| Biologic | 8 |
| Prophylactic biologic | 6 |
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
58 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 4 | 2 | 34 |
| 2 | Minoxidil Liniment | 4 | 2 | 52 |
| 3 | Finerenone Tablets | 3 | 2 | 69 |
| 4 | Pregabalin Capsules | 3 | 1 | 12 |
| 5 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
| 6 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 1 | 12 |
| 8 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
| 9 | Mesalazine Gastro-Resistant Prolonged-Release Granules | 2 | 1 | 3 |
| 10 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
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
200 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 2 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 4 | AstraZeneca AB | 5 | 2 | 0 |
| 5 | Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 7 | Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized | 4 | 4 | 3 |
| 8 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Amgen Manufacturing Limited LLC | 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/15Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2504283 | Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized |
| 2025/12/15Generic · Class 3 | Bempedoic Acid TabletsCYHL2500221 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/12/15New drug · Class 1 | GB19注射液 · No verified English nameCXSL2501081 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
| 2025/12/15New drug · Class 1 | GB19注射液 · No verified English nameCXSL2501080 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
| 2025/12/15New drug · Class 2.3 | 阿瑞匹坦帕洛诺司琼乳状注射液 · No verified English nameCXHS2500156 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/12/13Import · Class 1 | GIA632注射液 · No verified English nameJXSL2500238 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/12/13Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2504277 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized |
| 2025/12/13Generic · Class 3 | Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2504276 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized |
| 2025/12/13Generic · Class 3 | Tizanidine Hydrochloride TabletsCYHS2504272 | Kang Zhe (Hunan) Pharmaceutical Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2025/12/13Generic · Class 3 | 多种微量元素注射液(I) · No verified English nameCYHS2504271 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/12/13New drug · Class 1.1 | 小儿润通糖浆 · No verified English nameCXZL2500128 | Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized |
| 2025/12/13New drug · Class 3.3 | ACYW135群脑膜炎球菌结合疫苗 · No verified English nameCXSL2501077 | Chengdu Kang Hua Bio Zhi Pin Co., Ltd. romanized |
| 2025/12/13New drug · Class 2.2 | 盐酸多塞平口颊膜 · No verified English nameCXHS2500155 | Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized |
| 2025/12/13New drug · Class 1 | BGB-58067片 · No verified English nameCXHL2501385 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/12/13New drug · Class 1 | BGB-58067片 · No verified English nameCXHL2501384 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2025/12/12Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2504267 | Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized |
| 2025/12/12Generic · Class 3 | 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2504266 | Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized |
| 2025/12/12Generic · Class 3 | Indocyaninegreen for InjectionCYHS2504265 | Zhejiang Hang Kang Pharma Co., Ltd. romanized |
| 2025/12/12Generic · Class 3 | 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2504263 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized |
| 2025/12/12New drug · Class 2.2 | 斯鲁利单抗注射液 · No verified English nameCXSS2500141 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2025/12/12New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2501076 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/12New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2501075 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/12/12New drug · Class 1 | SM17单克隆抗体注射液(皮下注射) · No verified English nameCXSL2501074 | Xing Lian Pharma (Suzhou) Co., Ltd. romanized |
| 2025/12/12New drug · Class 1 | 注射用洛贝米柳 · No verified English nameCXHS2500154 | Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/12/12New drug · Class 2.4 | 戈利昔替尼胶囊 · No verified English nameCXHL2501383 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/12/11Generic · Class 3 | Dexrazoxane for InjectionCYHS2504264 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/12/11Generic · Class 3 | Benzbromarone TabletsCYHS2504255 | Zhejiang Hao Ge Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/12/11Generic · Class 3 | Minoxidil LinimentCYHS2504247 | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized |
| 2025/12/11Generic · Class 3 | Minoxidil LinimentCYHS2504246 | Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized |
| 2025/12/11Generic · Class 3 | 左氧氟沙星滴耳液 · No verified English nameCYHS2504245 | Yunnan Dai Yao Co., Ltd. romanized |
74 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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