YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 186 drug applications between 26 January 2025 and 1 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 46 drug names.
2025/01/26 – 2025/02/01
- New acceptances this week
- 186
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 6
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
186filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 65 |
| Supplement | 59 |
| New drug | 50 |
| Import re-registration | 6 |
| Import | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 142 |
| Therapeutic biologic | 30 |
| TCM | 11 |
| Prophylactic biologic | 2 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 3 | Finerenone Tablets | 3 | 2 | 69 |
| 4 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Potassium Chloride Oral Solution | 2 | 2 | 11 |
| 7 | 帕立骨化醇软胶囊 · No verified English name | 2 | 1 | 0 |
| 8 | Amoxicillin Sodium and Clavulanate Potassium for Injection | 2 | 1 | 4 |
| 9 | Loxoprofen Sodium Patches | 2 | 1 | 30 |
| 10 | Doxylamine Succinate Tablets | 2 | 1 | 0 |
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
123 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hangzhou Xin Yuan Su Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 2 | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 3 | Boehringer Ingelheim International GmbH | 4 | 1 | 0 |
| 4 | GUERBET | 4 | 1 | 0 |
| 5 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Hainan Zhong He Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Eli Lilly Nederland B.V. | 3 | 1 | 0 |
| 8 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 3 | 1 | 3 |
| 9 | Tong Lu Biopharmaceutical Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 3 | 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
75 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/28Generic · Class 3 | Calcium Acetate Oral SolutionCYHS2500553 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/01/28Generic · Class 3 | Oxytocin InjectionCYHS2500550 | Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized |
| 2025/01/28Generic · Class 3 | 碳酸氢钠/葡萄糖2mmol/L钾电解质血滤置换液 · No verified English nameCYHS2500549 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized |
| 2025/01/28Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2500547 | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2025/01/28New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSS2500022 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2025/01/28New drug · Class 1 | 重组抗人EGFR抗体/IL-10双特异Fc融合蛋白注射液 · No verified English nameCXSL2500098 | Shi Hui Da Pharma Group (Jilin) Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | 注射用SIM0686 · No verified English nameCXSL2500097 | Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | BNT327 · No verified English nameCXSL2500096 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | BNT326 · No verified English nameCXSL2500095 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
| 2025/01/28New drug · Class 1 | HRS-9813胶囊 · No verified English nameCXHL2500147 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/27Import · Class 1 | 普乐司兰钠注射液 · No verified English nameJXHS2500018 | Arrowhead Pharmaceuticals Inc.; Ajinomoto Althea Inc.; Visirna Therapeutics (Suzhou) Co. Ltd. |
| 2025/01/27Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2500545 | Wuhan Xin Rui Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Wu Jing Pharma Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2500535 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2500533 | Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | 多种微量元素注射液(Ⅳ) · No verified English nameCYHS2500521 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/01/27Generic · Class 3 | Doxylamine Succinate TabletsCYHS2500515 | Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized; Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Doxylamine Succinate TabletsCYHS2500514 | Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized; Yuan Da Sheng Ming Ke Xue (Shandong) Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2500513 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2500512 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2500511 | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Colchicine TabletsCYHS2500508 | Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Loxoprofen Sodium Oral SolutionCYHS2500506 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Acetylcysteine TabletsCYHS2500502 | Guangdong Tai Lai Run Zhi Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2500499 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Calcitriol Oral SolutionCYHS2500498 | Beijing Ren Zhong Pharma Co., Ltd. romanized; Hubei Xin Ze Fei Pharma Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2500497 | Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2025/01/27Generic · Class 3 | 伏环孢素软胶囊 · No verified English nameCYHL2500031 | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | Flurbiprofen PatchesCYHL2500030 | Jiangxi Kang En Bei Zhong Yao Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | 帕立骨化醇软胶囊 · No verified English nameCYHL2500029 | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized |
| 2025/01/27Generic · Class 3 | 帕立骨化醇软胶囊 · No verified English nameCYHL2500028 | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized |
45 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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