YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 368 drug applications between 17 January 2025 and 23 January 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 123, covering 86 drug names.
2025/01/17 – 2025/01/23
- New acceptances this week
- 368
- Drugs with new generic filings (by drug name, de-duplicated)
- 86
- Accepted this week, now under review
- 13
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
368filings, 123 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 153 |
| Generic | 123 |
| New drug | 67 |
| Import | 22 |
| Unspecified | 2 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 273 |
| TCM | 50 |
| Therapeutic biologic | 40 |
| Prophylactic biologic | 5 |
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
86 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 7 | 3 | 27 |
| 2 | Mivacurium Chloride Injection | 6 | 3 | 3 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Lactulose Oral Solution | 2 | 2 | 34 |
| 5 | Piracetam Injection | 2 | 2 | 9 |
| 6 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 2 | 2 |
| 7 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 8 | 盐酸纳美芬注射液 · No verified English name | 2 | 2 | 1 |
| 9 | Sodium Thiosulfate Injection | 2 | 2 | 3 |
| 10 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 3 |
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
237 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 8 | 6 | 0 |
| 2 | Yunnan Yi Zhi Hao Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 3 | Anhui Jin Ma Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | AstraZeneca AB | 5 | 4 | 0 |
| 5 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 5 | 3 | 5 |
| 6 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 5 | 3 | 1 |
| 7 | Fresenius Kabi AB | 5 | 1 | 0 |
| 8 | Bristol-Myers Squibb Company | 4 | 4 | 0 |
| 9 | Guizhou Heng He Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | 4 | 3 | 2 |
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
136 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/01/23Import · Class 1 | MT-7117 片 · No verified English nameJXHL2500014 | Mitsubishi Tanabe Pharma Corporation |
| 2025/01/23Generic · Class 3 | Levofloxacin InjectionCYHS2500444 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | Levofloxacin InjectionCYHS2500443 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | Pregabalin Orally Disintegrating TabletsCYHS2500442 | Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | Potassium Chloride InjectionCYHS2500440 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/01/23Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2500439 | Guangdong Jun Kang Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | Polaprezinc Orally Disintegrating TabletsCYHS2500438 | Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Wan Run Pharma Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2500435 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2500433 | Zhong Run Pharma Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | 利多卡因喷雾剂 · No verified English nameCYHS2500430 | Chongqing Xiang Xue Pharmaceuticals Co., Ltd. romanized; Guangzhou Shi Xiang Xue Pharmaceutical Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | 利多卡因喷雾剂 · No verified English nameCYHS2500429 | Chongqing Xiang Xue Pharmaceuticals Co., Ltd. romanized; Guangzhou Shi Xiang Xue Pharmaceutical Co., Ltd. romanized |
| 2025/01/23Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2500421 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2025/01/23Generic · Class 3 | Alendronate Sodium And Sodium Chloride InjectionCYHL2500022 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2025/01/23New drug · Class 1.1 | 安神滴丸 · No verified English nameCXZS2500002 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | BNT324 · No verified English nameCXSL2500073 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | BNT327 · No verified English nameCXSL2500072 | Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | TriCellPr-AC07人脐带间充质干细胞注射液 · No verified English nameCXSL2500071 | Ao Chen Bio (Yunnan) Co., Ltd. romanized |
| 2025/01/23New drug · Class 2.3 | 海博麦布阿托伐他汀钙片 · No verified English nameCXHS2500013 | Han Hui Pharmaceutical Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2025/01/23New drug · Class 2.3 | 海博麦布阿托伐他汀钙片 · No verified English nameCXHS2500012 | Han Hui Pharmaceutical Co., Ltd. romanized; Zhejiang Hai Zheng Pharma Co., Ltd. romanized |
| 2025/01/23New drug · Class 2.2 | CMC-2310口溶膜 · No verified English nameCXHL2500113 | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized |
| 2025/01/23New drug · Class 2.2 | CMC-2310口溶膜 · No verified English nameCXHL2500112 | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2500111 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2500110 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2500109 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | TQB3912片 · No verified English nameCXHL2500108 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/01/23New drug · Class 1 | TQB3912片 · No verified English nameCXHL2500107 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2025/01/23New drug · Class 2.4 | HK241雾化吸入溶液 · No verified English nameCXHL2500106 | Nanjing Hua Gai Pharmaceutical Co., Ltd. romanized |
| 2025/01/23New drug · Class 2.2 | BCM995 · No verified English nameCXHL2500105 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | BIOS-0618片 · No verified English nameCXHL2500104 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/01/23New drug · Class 1 | BIOS-0618片 · No verified English nameCXHL2500103 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
106 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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