YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 338 drug applications between 25 July 2023 and 31 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 55 drug names.
2023/07/25 – 2023/07/31
- New acceptances this week
- 338
- Drugs with new generic filings (by drug name, de-duplicated)
- 55
- Accepted this week, now under review
- 0
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
338filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 70 |
| New drug | 52 |
| Import | 20 |
| Import re-registration | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 236 |
| TCM | 50 |
| Therapeutic biologic | 46 |
| Prophylactic biologic | 5 |
| 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
55 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Topiroxostat Tablets | 4 | 2 | 0 |
| 2 | Roxatidine Acetate Hydrochloride For Injection | 2 | 2 | 5 |
| 3 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 4 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 5 | Pravastatin Sodium Tablets | 2 | 1 | 2 |
| 6 | Carfilzomib For Injection | 2 | 1 | 0 |
| 7 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 8 | Naloxone Hydrochloride Injection | 2 | 1 | 1 |
| 9 | Thioctic Acid Tablets | 2 | 1 | 4 |
| 10 | Mirabegron Extended-release Tablets | 2 | 1 | 1 |
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
182 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan He Li Xin Jian Pharma Co., Ltd. romanized | 15 | 14 | 0 |
| 2 | Guizhou Tian Di Pharma Co., Ltd. romanized | 12 | 3 | 0 |
| 3 | Hubei Qian Jiang Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Bayer AG | 9 | 2 | 0 |
| 5 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 7 | 2 | 0 |
| 6 | Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Liaoning Hua Rui Joint Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Sanofi Winthrop Industrie | 5 | 1 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 4 | 2 |
| 10 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/31Generic · Class 3 | Alprostadil InjectionCYHL2300094 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/07/31Generic · Class 3 | Topiroxostat TabletsCYHL2300093 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2023/07/31Generic · Class 3 | Topiroxostat TabletsCYHL2300092 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized |
| 2023/07/31New drug · Class 1 | LVGN7409单克隆抗体注射液 · No verified English nameCXSL2300528 | Li Jin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/07/31New drug · Class 3.4 | 马破伤风免疫球蛋白F(ab')2 · No verified English nameCXSL2300527 | Lanzhou Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/07/31New drug · Class 1 | ND-003片 · No verified English nameCXHL2300836 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2023/07/31New drug · Class 1 | ND-003片 · No verified English nameCXHL2300835 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2023/07/29Import · Class 1 | AZD2936 · No verified English nameJXSL2300145 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/07/29Generic · Class 3 | Thioctic Acid TabletsCYHS2302036 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/07/29Generic · Class 3 | Thioctic Acid TabletsCYHS2302035 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/07/29Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2302033 | Jiangsu Chang Jiang Pharma Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2023/07/29Generic · Class 3 | Bumetanide InjectionCYHS2302028 | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/07/29Generic · Class 3 | Topiroxostat TabletsCYHL2300090 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/07/29Generic · Class 3 | Topiroxostat TabletsCYHL2300089 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/07/29New drug · Class 1 | 注射用SG2918 · No verified English nameCXSL2300526 | Hangzhou Shang Jian Bio Technology Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | 注射用LM-302 · No verified English nameCXSL2300525 | Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | JMKX000197注射液 · No verified English nameCXHL2300834 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | JMKX000197注射液 · No verified English nameCXHL2300833 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | IMP1734片 · No verified English nameCXHL2300832 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | IMP1734片 · No verified English nameCXHL2300831 | Shanghai Ying Pai Pharma Co., Ltd. romanized |
| 2023/07/29New drug · Class 2.1 | HDM3010 · No verified English nameCXHL2300830 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | ENC0364胶囊 · No verified English nameCXHL2300829 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | ENC0364胶囊 · No verified English nameCXHL2300828 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2023/07/29New drug · Class 1 | ENC0364胶囊 · No verified English nameCXHL2300827 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2023/07/28Import · Class 3.1 | 奥瑞利珠单抗注射液 · No verified English nameJXSS2300065 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2023/07/28Import · Class 3.1 | 奥瑞利珠单抗注射液 · No verified English nameJXSS2300064 | Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300144 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300143 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 3.1 | 重组人促卵泡激素δ注射液 · No verified English nameJXSL2300142 | Ferring Pharmaceuticals A/S; Ferring Pharmaceuticals (Asia) Company Limited |
| 2023/07/28Import · Class 2.4 | ABL001片 · No verified English nameJXHL2300179 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
71 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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