YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 278 drug applications between 8 June 2023 and 14 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 52 drug names.
2023/06/08 – 2023/06/14
- New acceptances this week
- 278
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- 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
278filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 134 |
| Generic | 70 |
| New drug | 47 |
| Unspecified | 12 |
| Import | 11 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 197 |
| TCM | 37 |
| Therapeutic biologic | 33 |
| Prophylactic biologic | 6 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 3 | 1 | 34 |
| 2 | 注射用头孢哌酮钠舒巴坦钠(2:1) · No verified English name | 3 | 1 | 2 |
| 3 | Potassium Chloride Injection | 2 | 2 | 10 |
| 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 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 7 | Levocarnitine Injection | 2 | 1 | 4 |
| 8 | Potassium Chloride Granules | 2 | 1 | 4 |
| 9 | Methotrexate Injection | 2 | 1 | 11 |
| 10 | Urapidil Hydrochloride Injection | 2 | 1 | 6 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 5 | 2 | 2 |
| 2 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 3 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 3 | 4 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 5 | Xin Dong Sheng Ji Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Zhejiang Ya Tai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | GlaxoSmithKline Biologicals SA | 3 | 3 | 0 |
| 8 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Guangdong Luo Fu Shan Ge Hong Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Guangxi Tai Nuo Pharmaceutical 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
81 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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. |
| 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 nameCYHS2301613 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2023/06/13Generic · Class 3 | Methocarbamol InjectionCYHS2301612 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2023/06/13Generic · Class 3 | Ornidazole InjectionCYHS2301608 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized |
| 2023/06/13Generic · Class 3 | Furosemide InjectionCYHS2301607 | Wuhan Jiu An Pharma Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/06/13Generic · Class 3 | Furosemide InjectionCYHS2301606 | Wuhan Jiu An Pharma Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2023/06/13New drug · Class 1.3 | 马甲子胶囊 · No verified English nameCXZL2300040 | Chengdu Ma Jia Zi Bio Technology Co., Ltd. romanized |
| 2023/06/13New drug · Class 1 | 注射用SMP-656 · No verified English nameCXSL2300413 | Chengdu Ke Ling Yuan Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/13New drug · Class 2.2 | 恩沃利单抗注射液 · No verified English nameCXSL2300412 | Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized |
| 2023/06/13New drug · Class 1 | IBI355 · No verified English nameCXSL2300411 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/06/13New drug · Class 1 | IBI355 · No verified English nameCXSL2300410 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/06/13New drug · Class 1 | XNW21015片 · No verified English nameCXHL2300640 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/13New drug · Class 1 | XNW21015片 · No verified English nameCXHL2300639 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/13New drug · Class 1 | XNW21015片 · No verified English nameCXHL2300638 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/06/12New drug · Class 1.3 | 冻干人用CpG佐剂狂犬病疫苗(Vero细胞) · No verified English nameCXSL2300409 | Changchun Zhuo Yi Bio Co., Ltd. romanized |
51 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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