YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 359 drug applications between 8 November 2023 and 14 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 60 drug names.
2023/11/08 – 2023/11/14
- New acceptances this week
- 359
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- 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
359filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 95 |
| New drug | 51 |
| Import | 14 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 257 |
| TCM | 71 |
| Therapeutic biologic | 29 |
| Biologic | 1 |
| Prophylactic biologic | 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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Granules | 6 | 3 | 4 |
| 2 | Norepinephrine Bitartrate Injection | 6 | 3 | 9 |
| 3 | Ibuprofen Injection | 3 | 2 | 8 |
| 4 | Potassium Chloride Oral Solution | 3 | 2 | 11 |
| 5 | Minoxidil Liniment | 3 | 2 | 52 |
| 6 | Piracetam Injection | 3 | 1 | 9 |
| 7 | Neostigmine Methylsulfate Injection | 3 | 1 | 4 |
| 8 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 9 | Acipimox Capsules | 2 | 2 | 2 |
| 10 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 26 | 25 | 0 |
| 2 | Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized | 11 | 4 | 0 |
| 3 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 10 | 3 | 0 |
| 4 | Jiu Hua Hua Yuan Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | Sanofi Winthrop Industrie | 7 | 3 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 2 | 1 |
| 7 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 5 | 4 | 5 |
| 8 | Merck Sharp & Dohme LLC | 5 | 2 | 0 |
| 9 | Jilin Sheng Shen Lu Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Hebei Wan Bang Fu Lin Pharma 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
116 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/14Import · Class 3.1 | 注射用利纳西普(暂定) · No verified English nameJXSS2300084 | Kiniksa Pharmaceuticals (UK),Ltd.; Jubilant HollisterStier LLC; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICALS CO. LTD |
| 2023/11/14Import · Class 1 | Alnuctamab注射液 · No verified English nameJXSL2300195 | Celgene International II Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/11/14Import · Class 1 | Alnuctamab注射液 · No verified English nameJXSL2300194 | Celgene International II Sarl; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2023/11/14Import · Class 1 | RO7538483注射液 · No verified English nameJXSL2300193 | F. Hoffmann -La Roche Ltd; Roche (China) Holding Ltd |
| 2023/11/14Generic · Class 3 | Potassium Chloride GranulesCYHS2303127 | Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/11/14Generic · Class 3 | Potassium Chloride GranulesCYHS2303126 | Hebei San He Shi Chuang Bio Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2023/11/14Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2303121 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/11/14Generic · Class 3 | 布地奈德福莫特罗吸入气雾剂 · No verified English nameCYHS2303119 | Sichuan Pu Rui Te Pharma Co., Ltd. romanized |
| 2023/11/14Generic · Class 3 | Potassium Chloride GranulesCYHS2303118 | Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd |
| 2023/11/14Generic · Class 3 | Potassium Chloride GranulesCYHS2303117 | Chi Feng Gu De Pharma Co., Ltd. romanized; Zhejiang Nord Pharmaceutical Co., Ltd |
| 2023/11/14Generic · Class 3 | Minoxidil LinimentCYHS2303116 | Guangdong Pei Jie Drug Research Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2023/11/14Generic · Class 3 | Minoxidil LinimentCYHS2303115 | Guangdong Pei Jie Drug Research Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. |
| 2023/11/14Generic · Class 3 | Lidocaine Hydrochloride InjectionCYHS2303113 | Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Sui Cheng Pharma Co., Ltd. romanized |
| 2023/11/14Generic · Class 3 | Pirfenidone TabletsCYHL2300137 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2023/11/14New drug · Class 1 | SCTC21C注射液 · No verified English nameCXSL2300778 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2023/11/14New drug · Class 1.4 | 十五价重组人乳头瘤病毒疫苗(汉逊酵母) · No verified English nameCXSL2300777 | Chongqing Bo Wei Bai Tai Biopharmaceutical Co., Ltd. romanized; Shanghai Bo Wei Bio Technology Co., Ltd. romanized |
| 2023/11/14New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300776 | Beijing Bei Lai Bio Technology Co., Ltd. romanized; Beijing Bei Lai Pharma Co., Ltd. romanized |
| 2023/11/14New drug · Class 1 | 注射用LN005 · No verified English nameCXHL2301265 | Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized |
| 2023/11/14New drug · Class 1 | RGT-419B胶囊 · No verified English nameCXHL2301264 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2023/11/14New drug · Class 1 | RGT-419B胶囊 · No verified English nameCXHL2301263 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2023/11/13Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2303109 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2023/11/13Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2303108 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2023/11/13Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2303107 | Hangzhou Minsheng Pharmaceutical Co., Ltd |
| 2023/11/13Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2303106 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/11/13Generic · Class 3 | Diphenhydramine Hydrochloride TabletsCYHS2303105 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2023/11/11Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2300192 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2023/11/11Generic · Class 3 | Potassium Chloride GranulesCYHS2303100 | Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized |
| 2023/11/11Generic · Class 3 | Potassium Chloride GranulesCYHS2303099 | Shanxi Huang Cheng Xiang Fu Pharma Co., Ltd. romanized |
| 2023/11/11New drug · Class 1 | ZS805注射液 · No verified English nameCXSL2300775 | Sichuan Zhi Shan Wei Xin Bio Technology Co., Ltd. romanized |
| 2023/11/11New drug · Class 1 | 注射用MK-2870 · No verified English nameCXSL2300774 | Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized |
86 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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