YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 339 drug applications between 26 July 2023 and 1 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 57 drug names.
2023/07/26 – 2023/08/01
- New acceptances this week
- 339
- Drugs with new generic filings (by drug name, de-duplicated)
- 57
- 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
339filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 72 |
| New drug | 55 |
| Import | 18 |
| Import re-registration | 5 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 249 |
| TCM | 44 |
| Therapeutic biologic | 43 |
| Prophylactic 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
57 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 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 3 | Multiple Electrolytes Injection(Ⅱ) | 2 | 1 | 1 |
| 4 | Pravastatin Sodium Tablets | 2 | 1 | 2 |
| 5 | Carfilzomib For Injection | 2 | 1 | 0 |
| 6 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 7 | Neostigmine Methylsulfate Injection | 2 | 1 | 4 |
| 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
185 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Qian Jiang Pharmaceutical Co., Ltd. romanized | 20 | 18 | 0 |
| 2 | Bayer AG | 9 | 2 | 0 |
| 3 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Liaoning Hua Rui Joint Pharmaceutical Co., Ltd. romanized | 8 | 6 | 0 |
| 5 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 7 | 2 | 0 |
| 6 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 7 | 1 | 0 |
| 7 | Hong Xiang (Heilongjiang) Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Sanofi Winthrop Industrie | 5 | 1 | 0 |
| 9 | Sichuan He Zong Ze Hui Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/01Import · Class 1 | 注射用佐妥昔单抗 · No verified English nameJXSS2300066 | Astellas Pharma Europe B.V.; Baxter Oncology GmbH; Astellas (China) Investment Co. Ltd. |
| 2023/08/01Import · Class 1 | AAV5-hRKp.RPGR眼内注射溶液 · No verified English nameJXSL2300148 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/01Import · Class 1 | AAV5-hRKp.RPGR眼内注射溶液 · No verified English nameJXSL2300147 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/08/01Import · Class 1 | ES104 · No verified English nameJXSL2300146 | Elpiscience Biopharmaceuticals Co. Limited; Elpiscience (Suzhou) Biopharma Ltd. |
| 2023/08/01Import · Class 1 | MK-0616 片 · No verified English nameJXHL2300180 | Merck Sharp & Dohme LLC; Name not romanized |
| 2023/08/01Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2302055 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/08/01Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2302054 | Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/08/01Generic · Class 3 | 福多司坦片 · No verified English nameCYHS2302051 | Topfond Pharmaceutical Co., Ltd. |
| 2023/08/01Generic · Class 3 | Oxazepam TabletsCYHS2302048 | Hunan Dong Ting Pharma Co., Ltd. romanized |
| 2023/08/01Generic · Class 3 | Furosemide InjectionCYHS2302046 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2023/08/01Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2302042 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/08/01Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2302041 | Beijing Ya Bao Bio Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 1 | 依沃西单抗注射液 · No verified English nameCXSS2300061 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized; Kang Fang Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 1 | IBI343 · No verified English nameCXSL2300532 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/08/01New drug · Class 1 | 重组溶瘤腺病毒注射剂(KD01) · No verified English nameCXSL2300531 | Wuhan Kai De Ji Nuo Bio Technology Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSL2300530 | Guangzhou Yu Heng Bio Technology Co., Ltd. romanized |
| 2023/08/01New drug · Class 3.4 | 人凝血因子IX · No verified English nameCXSL2300529 | Guangdong Shuang Lin Biopharmaceutical Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300849 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300848 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300847 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300846 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300845 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300844 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 1 | HR1405-01注射液 · No verified English nameCXHL2300843 | Nanjing Hai Rong Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.2 | N2103肠溶胶囊 · No verified English nameCXHL2300842 | Jiangsu Hui Ju Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.2 | N2103肠溶胶囊 · No verified English nameCXHL2300841 | Jiangsu Hui Ju Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300840 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300839 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/08/01New drug · Class 2.1 | HZ-J001乳膏 · No verified English nameCXHL2300838 | Hubei Ren Fu Cheng Tian Pharma Co., Ltd. romanized |
| 2023/07/31Generic · Class 3 | Alprostadil InjectionCYHL2300094 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
73 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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