YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 291 drug applications between 25 January 2024 and 31 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 65 drug names.
2024/01/25 – 2024/01/31
- New acceptances this week
- 291
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 1
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
291filings, 87 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 121 |
| Generic | 87 |
| New drug | 51 |
| Import re-registration | 15 |
| Import | 13 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| TCM | 46 |
| Therapeutic biologic | 34 |
| Prophylactic biologic | 11 |
| Biologic | 3 |
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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 5 | 1 | 52 |
| 2 | Riociguat Tablets | 3 | 1 | 4 |
| 3 | Peramivir Injection | 2 | 2 | 7 |
| 4 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 5 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 6 | Tadalafil Tablets | 2 | 1 | 23 |
| 7 | Betamethasone Sodium Phosphate Injection | 2 | 1 | 5 |
| 8 | Risperidone Orally Disintegrating Tablets | 2 | 1 | 0 |
| 9 | Diquafosol Sodium Eye Drops | 2 | 1 | 5 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
189 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Fu Ren Jin Shen Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 2 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 7 | 4 | 7 |
| 3 | Pfizer Inc. | 7 | 3 | 0 |
| 4 | Sanofi -aventis France | 7 | 1 | 0 |
| 5 | Le Fu Si Health Industry Shareholding Company romanized | 5 | 1 | 5 |
| 6 | Xizang An Xing Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Merck Sharp & Dohme LLC | 4 | 1 | 0 |
| 8 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Novo Nordisk A/S | 3 | 3 | 0 |
| 10 | Jilin Sheng Zhang Yuan Pharma Co., Ltd. romanized | 3 | 3 | 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/01/31Import · Class 3.1 | Elranatamab注射液 · No verified English nameJXSS2400006 | Pfizer Inc.; Pharmacia & Upjohn Company LLC; Pfizer Investment Co. Ltd. |
| 2024/01/31Import · Class 3.1 | Elranatamab注射液 · No verified English nameJXSS2400005 | Pfizer Inc.; Pharmacia & Upjohn Company LLC; Pfizer Investment Co. Ltd. |
| 2024/01/31Import · Class 1 | Ulixacaltamide缓释片 · No verified English nameJXHL2400026 | Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2024/01/31Import · Class 1 | Ulixacaltamide缓释片 · No verified English nameJXHL2400025 | Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2024/01/31Import · Class 1 | Ulixacaltamide缓释片 · No verified English nameJXHL2400024 | Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2024/01/31Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2400417 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/01/31Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2400416 | Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/01/31Generic · Class 3 | Minoxidil LinimentCYHS2400414 | Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized |
| 2024/01/31Generic · Class 3 | Minoxidil LinimentCYHS2400413 | Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized |
| 2024/01/31Generic · Class 3 | Minoxidil LinimentCYHS2400412 | Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized |
| 2024/01/31Generic · Class 3 | Minoxidil LinimentCYHS2400411 | Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized |
| 2024/01/31Generic · Class 3 | Minoxidil LinimentCYHS2400410 | Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized |
| 2024/01/31Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2400406 | Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/01/31Generic · Class 3 | Proparacaine Hydrochloride Eye DropsCYHS2400405 | Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized |
| 2024/01/31Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2400404 | Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/01/31Generic · Class 3 | Piracetam InjectionCYHS2400403 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/01/31Generic · Class 3 | Peramivir InjectionCYHS2400400 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2024/01/31New drug · Class 1 | TQB2928注射液 · No verified English nameCXSL2400080 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | KSH01注射液 · No verified English nameCXSL2400079 | Ke Shi Hua (Shenzhen) Bio Technology Co., Ltd. romanized; Ke Shi Hua (Nanjing) Bio Technology Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | γδ-T细胞注射液 · No verified English nameCXSL2400078 | Guangdong Ji De Kang Min Bio Technology Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | 输注用SN-001浓缩冻干粉 · No verified English nameCXSL2400077 | Kunming Sai Nuo Pharmaceutical Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | 靶向GPC3装甲型嵌合抗原受体自体T细胞注射液C-CAR031 · No verified English nameCXSL2400076 | Shanghai Sai Bi Man Bio Technology Co., Ltd. romanized |
| 2024/01/31New drug · Class 1.1 | 六价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400075 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2024/01/31New drug · Class 1.1 | 六价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400074 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | KYS202003A注射液 · No verified English nameCXSL2400073 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/01/31New drug · Class 3.4 | 人凝血因子IX · No verified English nameCXSL2400072 | Chengdu Rong Sheng Pharma Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | BAT4406F注射液 · No verified English nameCXSL2400071 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/01/31New drug · Class 2.4 | 注射用BAT4306F · No verified English nameCXSL2400070 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | HSK31858片 · No verified English nameCXHL2400125 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
| 2024/01/31New drug · Class 1 | 注射用HYH2006078P1 · No verified English nameCXHL2400124 | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized |
66 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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