YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 264 drug applications between 9 June 2023 and 15 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 41 drug names.
2023/06/09 – 2023/06/15
- New acceptances this week
- 264
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- 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
264filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 132 |
| Generic | 55 |
| New drug | 46 |
| Unspecified | 16 |
| Import | 11 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 38 |
| Therapeutic biologic | 28 |
| Biologic | 5 |
| 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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name | 3 | 1 | 2 |
| 2 | Empagliflozin Tablets | 2 | 2 | 18 |
| 3 | Methocarbamol Injection | 2 | 2 | 3 |
| 4 | ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name | 2 | 1 | 0 |
| 5 | Furosemide Injection | 2 | 1 | 6 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Levocarnitine Injection | 2 | 1 | 4 |
| 8 | Potassium Chloride Granules | 2 | 1 | 4 |
| 9 | Perospirone Hydrochloride Tablets | 2 | 1 | 5 |
| 10 | Dopamine Hydrochloride Injection | 2 | 1 | 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
177 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 2 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 5 | 2 | 2 |
| 3 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 4 | Xin Dong Sheng Ji Co., Ltd. romanized | 4 | 1 | 0 |
| 5 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Zhejiang Ya Tai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Guangdong Luo Fu Shan Ge Hong Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 3 | 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
75 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/15Import · Class 1 | Obefazimod · No verified English nameJXHL2300139 | ABIVAX S.A.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2023/06/15Import · Class 1 | Obefazimod · No verified English nameJXHL2300138 | ABIVAX S.A.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2023/06/15Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2301634 | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized |
| 2023/06/15Generic · Class 3 | Methocarbamol InjectionCYHS2301627 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.3 | 百令胶囊 · No verified English nameCXZL2300041 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/06/15New drug · Class 1 | 注射用DB-1311 · No verified English nameCXSL2300418 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/06/15New drug · Class 1 | CUD002注射液 · No verified English nameCXSL2300417 | Sichuan Kang De Sai Medical Technology Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | 水合氯醛口服溶液 · No verified English nameCXHS2300054 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | 水合氯醛口服溶液 · No verified English nameCXHS2300053 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | MTS008缓释片 · No verified English nameCXHL2300650 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | MTS008缓释片 · No verified English nameCXHL2300649 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | MTS008缓释片 · No verified English nameCXHL2300648 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | MTS008缓释片 · No verified English nameCXHL2300647 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | 司美格鲁肽注射液 · No verified English nameCXHL2300646 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized; Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized |
| 2023/06/14Import · Class 1 | 盐酸伊普可泮胶囊 · No verified English nameJXHS2300050 | Novartis Pharma Schweiz AG; Novartis Pharma Produktions GmbH; Beijing Novartis Pharma Co. Ltd. |
| 2023/06/14Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂 · No verified English nameCYHS2301623 | Hubei Bang Ze Pharmaceuticals Co., Ltd. romanized; Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized |
| 2023/06/14Generic · Class 3 | Potassium Aspartate InjectionCYHS2301622 | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/06/14Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2301620 | Fujian Tian Quan Pharma Co., Ltd. romanized |
| 2023/06/14Generic · Class 3 | Ketorolac Tromethamine InjectionCYHS2301619 | Fujian Tian Quan Pharma Co., Ltd. romanized |
| 2023/06/14Generic · Class 3 | Sodium Picosulfate Oral SolutionCYHL2300077 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized |
| 2023/06/14New drug · Class 1 | EI-001注射液 · No verified English nameCXSL2300416 | An Li Xi Rong (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/14New drug · Class 1.1 | 肠道病毒71型-柯萨奇病毒A16型二价灭活疫苗(人二倍体细胞) · No verified English nameCXSL2300415 | Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized |
| 2023/06/14New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2300414 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/06/14New drug · Class 2.2 | RHYK2008 · No verified English nameCXHL2300645 | Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/14New drug · Class 2.2 | RHYK2008 · No verified English nameCXHL2300644 | Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/14New drug · Class 2.2 | RHYK2008 · No verified English nameCXHL2300643 | Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/14New drug · Class 2.4 | 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2300642 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/06/14New drug · Class 1 | LN020干混悬剂 · No verified English nameCXHL2300641 | Shandong Lu Ning Pharma Co., Ltd. romanized |
| 2023/06/13Import · Class 1 | STRO-002注射液(暂用) · No verified English nameJXSL2300106 | Sutro Biopharma Inc. |
| 2023/06/13Generic · Class 3 | ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHS2301614 | Sichuan Kelun Pharmaceutical Co., Ltd. |
45 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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