YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 331 drug applications between 21 November 2023 and 27 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 67 drug names.
2023/11/21 – 2023/11/27
- New acceptances this week
- 331
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- 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
331filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 153 |
| Generic | 95 |
| New drug | 46 |
| Import | 19 |
| Unspecified | 12 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 235 |
| TCM | 51 |
| Therapeutic biologic | 36 |
| Biologic | 6 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Granules | 4 | 2 | 4 |
| 2 | Brivaracetam Tablets | 4 | 1 | 19 |
| 3 | Latamoxef Sodium for Injection | 3 | 1 | 1 |
| 4 | Iohexol Injection | 3 | 1 | 5 |
| 5 | Tafluprost Eye Drops | 2 | 2 | 3 |
| 6 | Famotidine Injection | 2 | 2 | 8 |
| 7 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 8 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 9 | Torsemide Injection | 2 | 1 | 1 |
| 10 | Flumazenil Injection | 2 | 1 | 2 |
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
216 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized | 10 | 9 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Eli Lilly and Company | 5 | 1 | 0 |
| 5 | GUERBET | 5 | 1 | 0 |
| 6 | Merck Sharp & Dohme LLC | 5 | 1 | 0 |
| 7 | Novo Nordisk A/S | 5 | 1 | 0 |
| 8 | Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Shandong Jing Hui Bio Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 10 | Fresenius Kabi Austria GmbH | 4 | 1 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/27Import · Class 1 | MK-6194 注射液 · No verified English nameJXSL2300207 | Merck Sharp & Dohme LLC; Name not romanized |
| 2023/11/27Import · Class 1 | MK-6194 注射液 · No verified English nameJXSL2300206 | Merck Sharp & Dohme LLC; Name not romanized |
| 2023/11/27Import · Class 1 | MK-6194 注射液 · No verified English nameJXSL2300205 | Merck Sharp & Dohme LLC; Name not romanized |
| 2023/11/27Import · Class 1 | MK-6194 注射液 · No verified English nameJXSL2300204 | Merck Sharp & Dohme LLC; Name not romanized |
| 2023/11/27Import · Class 1 | MK-6194 注射液 · No verified English nameJXSL2300203 | Merck Sharp & Dohme LLC; Name not romanized |
| 2023/11/27New drug · Class 1 | ADG126注射液 · No verified English nameCXSL2300810 | Tian Yan Pharma (Suzhou) Co., Ltd. romanized |
| 2023/11/25Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2303264 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2023/11/25Generic · Class 3 | Ondansetron Hydrochloride TabletsCYHS2303263 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. |
| 2023/11/25Generic · Class 3 | Torsemide InjectionCYHS2303262 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2023/11/25Generic · Class 3 | Torsemide InjectionCYHS2303261 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Hunan Sai Long Pharma Co., Ltd. romanized |
| 2023/11/25Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2303260 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2023/11/25Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2303259 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2023/11/25Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2303257 | Jiangsu Li Tai Er Pharma Co., Ltd. romanized |
| 2023/11/25Generic · Class 3 | Famotidine InjectionCYHS2303256 | Guo Ren Health Pharmaceutical (Beijing) Co., Ltd. romanized; Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2023/11/25New drug · Class 1 | WG1025 · No verified English nameCXSL2300809 | Beijing Wei Yuan Li Kang Bio Technology Co., Ltd. romanized |
| 2023/11/25New drug · Class 1 | aT19注射液 · No verified English nameCXSL2300808 | Beijing Yong Tai Rui Ke Bio Technology Co., Ltd. romanized |
| 2023/11/25New drug · Class 1 | GP681片 · No verified English nameCXHS2300106 | Jiangxi Qing Feng Pharma Co., Ltd. romanized; Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Fudosteine oral solutionCYHS2303253 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Potassium Chloride InjectionCYHS2303251 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2303246 | Hebei Dong Sheng Ke Yu Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Potassium Chloride GranulesCYHS2303245 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Potassium Chloride GranulesCYHS2303244 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2303242 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shijiazhuang Yu Hui Pharmaceutical Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Flumazenil InjectionCYHS2303241 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | Flumazenil InjectionCYHS2303240 | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized |
| 2023/11/24Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2303239 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
| 2023/11/24New drug · Class 1.1 | 辛芪通鼻片 · No verified English nameCXZS2300024 | Beijing Yi Ling Pharma Co., Ltd. romanized; Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | B013注射液 · No verified English nameCXSL2300807 | Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | GR2102注射液 · No verified English nameCXSL2300806 | Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized; Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2023/11/24New drug · Class 1 | GR1802注射液 · No verified English nameCXSL2300805 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
72 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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