YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 261 drug applications between 24 May 2023 and 30 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 46 drug names.
2023/05/24 – 2023/05/30
- New acceptances this week
- 261
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 3
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
261filings, 66 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 127 |
| Generic | 66 |
| New drug | 33 |
| Import | 16 |
| Import re-registration | 14 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| TCM | 48 |
| Therapeutic biologic | 27 |
| Prophylactic biologic | 4 |
| 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
46 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oxacillin Sodium for Injection | 5 | 2 | 13 |
| 2 | Roxadustat Capsules | 4 | 2 | 17 |
| 3 | Phloroglucinol Injection | 3 | 3 | 2 |
| 4 | Selexipag Tablets | 3 | 1 | 24 |
| 5 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 6 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 7 | Carfilzomib For Injection | 3 | 1 | 0 |
| 8 | Doxofylline Injection | 2 | 1 | 5 |
| 9 | Naloxone Hydrochloride Injection | 2 | 1 | 1 |
| 10 | Minoxidil Topical Solution | 2 | 1 | 0 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 6 | 1 | 0 |
| 2 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Pfizer Inc. | 4 | 2 | 0 |
| 5 | NAPP PHARMACEUTICALS LIMITED | 4 | 1 | 0 |
| 6 | Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 3 | 2 | 0 |
| 8 | Anhui Lei Yun Shang Pharma Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 3 | 2 | 2 |
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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/30Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2300040 | Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2023/05/30Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2300133 | AbbVie Inc. |
| 2023/05/30Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2300132 | AbbVie Inc. |
| 2023/05/30Generic · Class 3 | Furosemide InjectionCYHS2301453 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2301452 | Shijiazhuang Kang Li Pharma Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2301451 | Shenzhen Shi Bei Mei Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301449 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301448 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2301447 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | Magnesium Sulfate InjectionCYHS2301445 | Chongqing Yao Gu Pharmaceutical Co., Ltd. romanized; Ji Chuan Pharma Group Co., Ltd. romanized |
| 2023/05/30Generic · Class 3 | 去氧肾上腺素酮咯酸溶液 · No verified English nameCYHS2301443 | Suzhou Lang Yi Biopharmaceuticals Research Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/05/30New drug · Class 1 | QL1706H注射液 · No verified English nameCXSL2300380 | Qilu Pharmaceutical Co., Ltd. |
| 2023/05/30New drug · Class 1 | 血液净化用间充质干细胞 · No verified English nameCXSL2300379 | Guangdong Qian Hui Bio Technology Co., Ltd. romanized |
| 2023/05/30New drug · Class 1 | sbk002片 · No verified English nameCXHS2300051 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2023/05/30New drug · Class 2.3 | B0125 · No verified English nameCXHL2300582 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/30New drug · Class 2.3 | B0125 · No verified English nameCXHL2300581 | Guangzhou Di Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/27Import · Class 1 | OMTX705注射用浓溶液 · No verified English nameJXSL2300098 | InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd |
| 2023/05/27Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300131 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300130 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300129 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300128 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300127 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 1 | LY3502970胶囊 · No verified English nameJXHL2300126 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/05/27Import · Class 2.4 | 盐酸醋克利定滴眼液 · No verified English nameJXHL2300125 | LENZ Therapeutics Inc.; Ji Xing Pharmaceuticals (Shanghai) Co.,Ltd |
| 2023/05/27Import · Class 2.3; 2.4 | 醋克利定溴莫尼定滴眼液 · No verified English nameJXHL2300124 | LENZ Therapeutics Inc.; Ji Xing Pharmaceuticals (Shanghai) Co.,Ltd |
| 2023/05/27Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2301442 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/05/27Generic · Class 3 | Indobufen TabletsCYHS2301441 | Shandong Lu Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/27Generic · Class 3 | Carbocisteine Oral SolutionCYHS2301440 | Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2023/05/27Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301439 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2023/05/27Generic · Class 3 | Famotidine InjectionCYHS2301437 | Nanjing Kang Fa Bio Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
44 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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