YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 514 drug applications between 5 January 2025 and 11 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 213, covering 150 drug names.
2025/01/05 – 2025/01/11
- New acceptances this week
- 514
- Drugs with new generic filings (by drug name, de-duplicated)
- 150
- Accepted this week, now under review
- 14
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
514filings, 213 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 213 |
| Supplement | 189 |
| New drug | 89 |
| Import | 13 |
| Unspecified | 4 |
| Import re-registration | 4 |
| Drug-device combination | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 379 |
| TCM | 70 |
| Therapeutic biologic | 60 |
| Biologic | 3 |
| 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
150 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Azilsartan Medoxomil Potassium Tablets | 6 | 3 | 35 |
| 2 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 5 | 2 | 12 |
| 3 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 4 | 4 | 9 |
| 4 | Brexpiprazole Tablets | 4 | 2 | 31 |
| 5 | Dapagliflozin Tablets | 4 | 2 | 84 |
| 6 | Crisaborole Ointment | 3 | 3 | 26 |
| 7 | Apalutamide Tablets | 3 | 3 | 18 |
| 8 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 9 | Levocarnitine Oral Solution | 3 | 2 | 9 |
| 10 | Etoricoxib Tablets | 3 | 1 | 8 |
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
298 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 20 | 18 | 0 |
| 2 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 13 | 12 | 0 |
| 3 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 7 | 1 | 0 |
| 4 | Shandong Qidu Pharmaceutical Co., Ltd. | 6 | 6 | 5 |
| 5 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 6 | 5 | 6 |
| 6 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 5 | 4 | 5 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 0 |
| 8 | Beijing Foyou Pharma CO.,LTD | 5 | 3 | 5 |
| 9 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 10 | Takeda Development Center Americas Inc. | 5 | 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
179 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/11Import · Class 1 | AZD2936 · No verified English nameJXSL2500007 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/01/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2500008 | Takeda Development Center Americas Inc. |
| 2025/01/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2500007 | Takeda Development Center Americas Inc. |
| 2025/01/11Import · Class 1 | TAK-360片 · No verified English nameJXHL2500006 | Takeda Development Center Americas Inc. |
| 2025/01/11Generic · Class 3 | Propranolol Hydrochloride TabletsCYHS2500261 | Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2500260 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2500259 | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2500249 | Shandong Qidu Pharmaceutical Co., Ltd.; Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | 氯雷他定口服溶液 · No verified English nameCYHS2500246 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | 氯雷他定口服溶液 · No verified English nameCYHS2500245 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | Indocyaninegreen for InjectionCYHS2500244 | Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | Brivaracetam Solution for InjectionCYHS2500242 | Jiangxi Ke Rui Pharma Co., Ltd. romanized; Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | 阿瑞匹坦注射液 · No verified English nameCYHL2500016 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/01/11Generic · Class 3 | 尿素[13C]呼气试验药盒 · No verified English nameCYHL2500015 | Fu Rui Sen Bio Technology (Kun Shan) Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | 尿素[13C]呼气试验药盒 · No verified English nameCYHL2500014 | Fu Rui Sen Bio Technology (Kun Shan) Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | 利多卡因软膏 · No verified English nameCYHL2500013 | Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/11Generic · Class 3 | 利多卡因软膏 · No verified English nameCYHL2500012 | Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/11New drug · Class 3.1 | 清金化痰颗粒 · No verified English nameCXZS2500001 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/01/11New drug · Class 1 | ZHB117舌下片 · No verified English nameCXSL2500037 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2025/01/11New drug · Class 1 | ZHB117舌下片 · No verified English nameCXSL2500036 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2025/01/11New drug · Class 2.2 | 布瑞哌唑口服混悬液 · No verified English nameCXHS2500007 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/01/11New drug · Class 1 | KHN702片 · No verified English nameCXHL2500057 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2025/01/11New drug · Class 1 | KHN702片 · No verified English nameCXHL2500056 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2025/01/11New drug · Class 1 | KHN702片 · No verified English nameCXHL2500055 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2025/01/11New drug · Class 2.2 | XZ157 · No verified English nameCXHL2500054 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Minoxidil LinimentCYHS2500239 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Minoxidil LinimentCYHS2500238 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Bumetanide InjectionCYHS2500229 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Jiangsu Su Zhong Pharma Group Biopharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Magnesium Sulfate InjectionCYHS2500228 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2025/01/10Generic · Class 3 | Indocyaninegreen for InjectionCYHS2500221 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
149 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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