YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 354 drug applications between 7 July 2023 and 13 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 64 drug names.
2023/07/07 – 2023/07/13
- New acceptances this week
- 354
- Drugs with new generic filings (by drug name, de-duplicated)
- 64
- 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
354filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 173 |
| Generic | 80 |
| New drug | 67 |
| Import | 17 |
| Import re-registration | 13 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 271 |
| Therapeutic biologic | 39 |
| TCM | 35 |
| Prophylactic biologic | 9 |
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
64 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Oral Solution | 3 | 2 | 11 |
| 2 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 3 | Methocarbamol Injection | 2 | 2 | 3 |
| 4 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 5 | 复方奥美拉唑干混悬剂 · No verified English name | 2 | 1 | 0 |
| 6 | 头孢羟氨苄片 · No verified English name | 2 | 1 | 0 |
| 7 | Oxcarbazepine Tablets | 2 | 1 | 4 |
| 8 | 泊马度胺胶囊 · No verified English name | 2 | 1 | 4 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 10 | Oxacillin Sodium for Injection | 2 | 1 | 13 |
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
213 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Brilliant Pharmaceutical Co., Ltd. | 15 | 3 | 0 |
| 2 | AstraZeneca AB | 8 | 5 | 0 |
| 3 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Upjohn Manufacturing Ireland Unlimited Company | 6 | 1 | 0 |
| 5 | Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 2 |
| 6 | Intas Pharmaceuticals. Ltd. | 5 | 1 | 0 |
| 7 | Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 4 | 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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/13Import · Class 3.1 | 注射用泰朗妥昔单抗 · No verified English nameJXSS2300057 | ADC Therapeutics SA; BSP Pharmaceuticals S.p.A.; Overland Pharmaceuticals (Shanghai) Co. Ltd. |
| 2023/07/13Import · Class 1 | Lu AF82422 注射液 · No verified English nameJXSL2300128 | H. Lundbeck A/S |
| 2023/07/13Generic · Class 3 | Landiolol Hydrochloride for InjectionCYHS2301892 | Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2023/07/13Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301889 | Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2023/07/13Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301888 | Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2023/07/13Generic · Class 3 | Famotidine InjectionCYHS2301883 | Yunnan Xian Shi Pharma Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized |
| 2023/07/13Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2301878 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2023/07/13Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2300087 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/07/13Generic · Class 3 | Cariprazine hydrochloride CapsulesCYHL2300086 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2023/07/13Generic · Class 3 | Nelarabine injectionCYHL2300085 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/07/13New drug · Class 1.1 | 六黄止渴颗粒 · No verified English nameCXZL2300047 | Guangdong Kai Zhong Bio Technology Co., Ltd. romanized |
| 2023/07/13New drug · Class 1.2 | 复制缺陷型猴痘疫苗 · No verified English nameCXSL2300478 | Beijing Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/07/13New drug · Class 3.3 | QL2107注射液 · No verified English nameCXSL2300477 | Qilu Pharmaceutical Co., Ltd. |
| 2023/07/13New drug · Class 1 | 注射用TGI-6 · No verified English nameCXSL2300476 | Hefei Tian Gang Mian Yi Drug Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | HT006.2.2滴眼液 · No verified English nameCXSL2300475 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | HT006.2.2滴眼液 · No verified English nameCXSL2300474 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | HT006.2.2滴眼液 · No verified English nameCXSL2300473 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | HT006.2.2滴眼液 · No verified English nameCXSL2300472 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | IBI363 · No verified English nameCXSL2300471 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2300470 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2023/07/13New drug · Class 2.4 | 植物源重组瑞替普酶 · No verified English nameCXSL2300468 | Wuhan He Yuan Bio Technology Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | APGT-001片 · No verified English nameCXHL2300778 | Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | APGT-001片 · No verified English nameCXHL2300777 | Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | APGT-001片 · No verified English nameCXHL2300776 | Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | 甲苯磺酸艾贝司他片 · No verified English nameCXHL2300775 | Xu Nuo Pharma (Nanjing) Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | SAL0120片 · No verified English nameCXHL2300774 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | SAL0120片 · No verified English nameCXHL2300773 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2023/07/13New drug · Class 1 | HP007注射液 · No verified English nameCXHL2300772 | Hua Pu Bio Technology (Hebei) Co., Ltd. romanized; Jiangsu Tai Pu Rui Bio Technology Co., Ltd. romanized |
| 2023/07/12Import · Class 2.4 | 盐酸替纳帕诺片 · No verified English nameJXHS2300064 | Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited |
| 2023/07/12Import · Class 2.4 | 盐酸替纳帕诺片 · No verified English nameJXHS2300063 | Ardelyx Inc.; Patheon Pharmaceuticals Inc.; Shanghai Fosun Pharmaceutical Industrial Development Company Limited |
87 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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