YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 332 drug applications between 13 November 2024 and 19 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 103, covering 73 drug names.
2024/11/13 – 2024/11/19
- New acceptances this week
- 332
- Drugs with new generic filings (by drug name, de-duplicated)
- 73
- Accepted this week, now under review
- 7
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
332filings, 103 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 147 |
| Generic | 103 |
| New drug | 56 |
| Import | 14 |
| Unspecified | 7 |
| Import re-registration | 4 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 238 |
| TCM | 52 |
| Therapeutic biologic | 29 |
| Prophylactic biologic | 9 |
| Biologic | 3 |
| In vitro diagnostic reagent | 1 |
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
73 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fluoxetine Hydrochloride Oral Solution | 4 | 1 | 0 |
| 2 | Glucosamine Sulfate Capsules | 3 | 3 | 51 |
| 3 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Pregabalin Oral Solution | 3 | 1 | 5 |
| 6 | Tobramycin Eye Drops | 2 | 2 | 2 |
| 7 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 8 | Isavuconazonium Sulfate for Injection | 2 | 2 | 15 |
| 9 | Sodium Bicarbonate Injection | 2 | 2 | 10 |
| 10 | 西格列汀二甲双胍片(Ⅰ) · No verified English name | 2 | 2 | 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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized | 6 | 4 | 0 |
| 2 | Celgene Corporation | 6 | 1 | 0 |
| 3 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Novartis Pharma Schweiz AG | 4 | 3 | 0 |
| 7 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Bristol-Myers Squibb Australia Pty Ltd | 4 | 1 | 0 |
| 9 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Chengdu Di Kang Pharma 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/19Import · Class 1 | VAY736注射液 · No verified English nameJXSL2400223 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/11/19Import · Class 1 | INCB057643片 · No verified English nameJXHL2400269 | Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd. |
| 2024/11/19Import · Class 1 | INCB057643片 · No verified English nameJXHL2400268 | Incyte Corporation; Incyte Biosciences Shanghai Co. Ltd. |
| 2024/11/19Generic · Class 3 | Doxofylline GranulesCYHS2403960 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/11/19Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2403958 | Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/11/19Generic · Class 3 | Mannitol-S InjectionCYHL2400229 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSS2400124 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | JSKN033注射液 · No verified English nameCXSL2400787 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2024/11/19New drug · Class 2.2 | A140注射液 · No verified English nameCXSL2400786 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | 注射用BGB-A3055 · No verified English nameCXSL2400785 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | GLS-W1100胶囊 · No verified English nameCXSL2400784 | Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | HX044注射液 · No verified English nameCXSL2400783 | Han Si Ai Tai Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401257 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401256 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401255 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/19New drug · Class 2.4 | 格索雷塞片 · No verified English nameCXHL2401254 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/11/19New drug · Class 2.4 | 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2401253 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | 注射用ZHB601 · No verified English nameCXHL2401252 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401251 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401250 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/19New drug · Class 1 | SYHA1813口服溶液 · No verified English nameCXHL2401249 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/18Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403955 | Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Si Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/18Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2403952 | Hubei Duo Rui Pharma Co., Ltd. romanized |
| 2024/11/18Generic · Class 3 | Epalrestat TabletsCYHS2403950 | Guangdong Jiu Ming Pharmaceutical Co., Ltd. romanized |
| 2024/11/18Generic · Class 3 | 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2403949 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized |
| 2024/11/18New drug · Class 2.2 | 恩朗苏拜单抗注射液 · No verified English nameCXSL2400782 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/11/18New drug · Class 2.4 | 注射用KJ101 · No verified English nameCXSL2400781 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2024/11/16Import · Class 1 | JNJ-77242113-AAC片 · No verified English nameJXHL2400267 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2024/11/16Generic · Class 3 | 右美沙芬安非他酮缓释片 · No verified English nameCYHL2400228 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/11/16New drug · Class 1 | 注射用SKB445 · No verified English nameCXSL2400780 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
74 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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