YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 495 drug applications between 31 January 2026 and 6 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 63 drug names.
2026/01/31 – 2026/02/06
- New acceptances this week
- 495
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 138
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
495filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 297 |
| Generic | 92 |
| New drug | 63 |
| Import re-registration | 17 |
| Unspecified | 16 |
| Import | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 255 |
| TCM | 181 |
| Therapeutic biologic | 51 |
| Biologic | 7 |
| Prophylactic biologic | 1 |
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
63 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | Cyclophosphamide Injection | 3 | 1 | 6 |
| 3 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 4 | 莫立司他钠片 · No verified English name | 3 | 1 | 0 |
| 5 | Ibuprofen Suspension | 2 | 2 | 14 |
| 6 | 氧 · No verified English name | 2 | 2 | 15 |
| 7 | Dapagliflozin Tablets | 2 | 2 | 84 |
| 8 | Fluticasone Propionate Cream | 2 | 1 | 12 |
| 9 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 10 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | 60 | 46 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 45 | 23 | 0 |
| 3 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 21 | 20 | 0 |
| 4 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 10 | 8 | 0 |
| 5 | Bayer AG | 6 | 2 | 0 |
| 6 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 6 | 2 | 0 |
| 7 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Jiangxi Wang Shi Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Ai Min Pharma Group Co., Ltd. romanized | 5 | 5 | 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
108 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/06Import · Class 1 | 伊利尤单抗注射液 · No verified English nameJXSS2600007 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2026/02/06Import · Class 1 | 伊利尤单抗注射液 · No verified English nameJXSS2600006 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2026/02/06Import · Class 2.4 | 宗艾替尼片 · No verified English nameJXHL2600032 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2026/02/06Generic · Class 3 | Amikacin Sulfate injectionCYHS2600409 | Shandong An Xin Pharmaceutical Co., Ltd. romanized; Qilu Pharmaceutical Co., Ltd. |
| 2026/02/06Generic · Class 3 | 二硫化硒洗剂 · No verified English nameCYHS2600398 | Hainan Yao Gu Yun Bio Technology Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized |
| 2026/02/06Generic · Class 3 | 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2600396 | Hua Ren Pharma Co., Ltd. romanized |
| 2026/02/06Generic · Class 3 | 利格列汀二甲双胍缓释片(Ⅱ) · No verified English nameCYHS2600392 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2026/02/06Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2600388 | Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized |
| 2026/02/06Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2600387 | Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized |
| 2026/02/06Generic · Class 3 | Amisulpride Oral SolutionCYHS2600386 | Wuhan Yi Bo Yuan Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized |
| 2026/02/06Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2600385 | Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized |
| 2026/02/06Generic · Class 3 | Cabozantinib TabletsCYHL2600021 | Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized |
| 2026/02/06New drug · Class 3.1 | 达原饮颗粒 · No verified English nameCXZS2600013 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2026/02/06New drug · Class 3.3 | 度拉糖肽注射液 · No verified English nameCXSS2600015 | Beijing SL Pharmaceutical Co., Ltd. |
| 2026/02/06New drug · Class 1.2 | 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2600181 | Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/02/06New drug · Class 3.3 | 度普利尤单抗注射液 · No verified English nameCXSL2600180 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/06New drug · Class 2.2 | 重组人神经生长因子滴眼液 · No verified English nameCXSL2600179 | Chongqing Ke Run Biopharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/02/06New drug · Class 2.2 | 重组人神经生长因子滴眼液 · No verified English nameCXSL2600178 | Chongqing Ke Run Biopharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/02/06New drug · Class 1 | 甲磺酸艾多替尼片 · No verified English nameCXHS2600026 | Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2026/02/06New drug · Class 2.4; 2.2 | BH015注射液 · No verified English nameCXHL2600154 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized |
| 2026/02/06New drug · Class 1 | 注射用JKN2502 · No verified English nameCXHL2600153 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2026/02/06New drug · Class 2.1; 2.2; 2.4 | H009L注射液 · No verified English nameCXHL2600152 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2600381 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | 盐酸溴己新吸入溶液 · No verified English nameCYHS2600380 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | 盐酸溴己新吸入溶液 · No verified English nameCYHS2600379 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Cyclophosphamide InjectionCYHS2600376 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Cyclophosphamide InjectionCYHS2600375 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Cyclophosphamide InjectionCYHS2600374 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2026/02/05Generic · Class 3 | Ferrous Succinate TabletsCYHS2600370 | Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized |
| 2026/02/05New drug · Class 1.1 | 双鱼颗粒 · No verified English nameCXZS2600012 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
78 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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