YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 403 drug applications between 5 February 2025 and 11 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 147, covering 101 drug names.
2025/02/05 – 2025/02/11
- New acceptances this week
- 403
- Drugs with new generic filings (by drug name, de-duplicated)
- 101
- Accepted this week, now under review
- 18
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
403filings, 147 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 147 |
| Supplement | 125 |
| New drug | 91 |
| Import | 22 |
| Import re-registration | 12 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 301 |
| Therapeutic biologic | 61 |
| TCM | 35 |
| Prophylactic biologic | 4 |
| 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
101 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 11 | 7 | 60 |
| 2 | Brexpiprazole Tablets | 8 | 3 | 31 |
| 3 | Tacrolimus Capsules | 4 | 2 | 2 |
| 4 | 盐酸纳美芬注射液 · No verified English name | 3 | 2 | 1 |
| 5 | Azilsartan Medoxomil Potassium Tablets | 3 | 2 | 35 |
| 6 | Polidocanol Injection | 3 | 1 | 23 |
| 7 | Tofacitinib Citrate Extended Release tablets | 2 | 2 | 2 |
| 8 | Sacubitril Valsartan Sodium Tablets | 2 | 2 | 70 |
| 9 | Cetrorelix Acetate for Injection | 2 | 2 | 4 |
| 10 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 9 |
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
248 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 11 | 3 | 0 |
| 2 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 9 | 3 | 0 |
| 3 | Novartis Pharma AG | 6 | 4 | 0 |
| 4 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 6 | 4 | 3 |
| 5 | Heilongjiang Shen Xing Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 5 | 4 | 5 |
| 7 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 8 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Beijing Hua Shen Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Janssen Research & Development 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
151 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/11Import · Class 2.2 | 美泊利珠单抗注射液 · No verified English nameJXSS2500006 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2025/02/11Import · Class 2.2 | 美泊利珠单抗注射液 · No verified English nameJXSS2500005 | GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited |
| 2025/02/11Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSS2500004 | Ipsen Pharma; Q-Med AB; Q-Med International Trading (Shanghai) Co. Ltd |
| 2025/02/11Import · Class 1 | Nipocalimab注射液 · No verified English nameJXSL2500022 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/11Import · Class 1 | LOU064片 · No verified English nameJXHL2500026 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/02/11Import · Class 1 | LOU064片 · No verified English nameJXHL2500025 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/02/11Import · Class 1 | LOU064片 · No verified English nameJXHL2500024 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/02/11Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2500693 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized |
| 2025/02/11Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2500692 | Hubei Qian Long Pharma Co., Ltd. romanized |
| 2025/02/11Generic · Class 3 | Dipyridamole TabletsCYHS2500691 | Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Di Yi Pharmaceutical Co., Ltd. romanized |
| 2025/02/11Generic · Class 3 | Acetazolamide Extended-release CapsulesCYHL2500037 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/02/11Generic · Class 3 | 血管紧张素Ⅱ注射液 · No verified English nameCYHL2500036 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2025/02/11New drug · Class 1.1 | 穿虎祛痛颗粒 · No verified English nameCXZL2500009 | Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized |
| 2025/02/11New drug · Class 1 | CM326注射液 · No verified English nameCXSL2500133 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/02/11New drug · Class 1 | CM326注射液 · No verified English nameCXSL2500132 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/02/11New drug · Class 2.2 | BTS0327 · No verified English nameCXHL2500192 | Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized |
| 2025/02/11New drug · Class 1 | MT-1207缓释片 · No verified English nameCXHL2500191 | Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized |
| 2025/02/11New drug · Class 1 | MT-1207缓释片 · No verified English nameCXHL2500190 | Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized |
| 2025/02/11New drug · Class 1 | MT-1207缓释片 · No verified English nameCXHL2500189 | Yuan Yan Yao Gang Sheng Ming Ke Xue (Liaoning) Group Co., Ltd. romanized |
| 2025/02/11New drug · Class 2.2; 2.4 | PA9060乳膏 · No verified English nameCXHL2500188 | Anhui Lao Si Duo Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/11New drug · Class 2.3 | 普卢格列汀二甲双胍缓释片(Ⅱ) · No verified English nameCXHL2500187 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/02/11New drug · Class 2.2; 2.4 | PA9060乳膏 · No verified English nameCXHL2500186 | Anhui Lao Si Duo Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/02/11New drug · Class 2.3 | 普卢格列汀二甲双胍缓释片(Ⅰ) · No verified English nameCXHL2500185 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/02/10New drug · Class 1.1 | 复方芎蕲软胶囊 · No verified English nameCXZL2500008 | Sichuan Sheng Zhong Pharmaceuticals Ke College (Sichuan Sheng Zhong Yao Research Institute) romanized; Zhongguo Ke College Lanzhou Chemical Wu Li Research Institute romanized |
| 2025/02/10New drug · Class 1 | 自体淋巴细胞注射液 · No verified English nameCXSL2500131 | Kang Ai Rui Hao Biopharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2025/02/10New drug · Class 2.3 | DYTH201片 · No verified English nameCXHL2500184 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2025/02/10New drug · Class 2.3 | DYTH201片 · No verified English nameCXHL2500183 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2025/02/09Import · Class 1 | Bleximenib片 · No verified English nameJXHL2500023 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 1 | Bleximenib片 · No verified English nameJXHL2500022 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2025/02/09Import · Class 1 | Bleximenib片 · No verified English nameJXHL2500021 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
121 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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