YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 352 drug applications between 20 May 2023 and 26 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 44 drug names.
2023/05/20 – 2023/05/26
- New acceptances this week
- 352
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- 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
352filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 192 |
| Generic | 70 |
| New drug | 59 |
| Import re-registration | 18 |
| Import | 7 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 247 |
| TCM | 62 |
| Therapeutic biologic | 38 |
| 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Roxadustat Capsules | 12 | 6 | 17 |
| 2 | Ropivacaine hydrochloride injection | 4 | 1 | 5 |
| 3 | Minoxidil Topical Solution | 3 | 2 | 0 |
| 4 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 5 | Carfilzomib For Injection | 3 | 1 | 0 |
| 6 | Oxacillin Sodium for Injection | 3 | 1 | 13 |
| 7 | Phloroglucinol Injection | 2 | 2 | 2 |
| 8 | Nicorandil for Injection | 2 | 1 | 1 |
| 9 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
| 10 | Naloxone Hydrochloride Injection | 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
196 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Lang De Pharma Co., Ltd. romanized | 32 | 14 | 0 |
| 2 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 12 | 11 | 0 |
| 3 | UCB Pharma SA | 6 | 1 | 0 |
| 4 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Guang Sheng Yuan Zhong Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | AstraZeneca AB | 4 | 2 | 0 |
| 8 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 10 | Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized | 4 | 2 | 1 |
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
88 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/26Generic · Class 3 | Minoxidil Topical SolutionCYHS2301430 | Jiangsu Run Bang Pharma Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/05/26Generic · Class 3 | Minoxidil Topical SolutionCYHS2301429 | Jiangsu Run Bang Pharma Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2023/05/26Generic · Class 3 | Fluorouracil InjectionCYHS2301428 | Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/05/26Generic · Class 3 | Pregabalin Oral SolutionCYHS2301427 | Haerbin Shi Kang Long Pharma Co., Ltd. romanized |
| 2023/05/26Generic · Class 3 | Haloperidol Lactate InjectionCYHS2301426 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/05/26New drug · Class 1.1 | 麻荆宣肺颗粒 · No verified English nameCXZL2300037 | Zhongguo Zhong Yi Ke College Xi Yuan Hospital romanized |
| 2023/05/26New drug · Class 1.4 | 口服六价重配轮状病毒活疫苗(Vero细胞) · No verified English nameCXSS2300039 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/05/26New drug · Class 2.2 | 四价流感病毒亚单位疫苗(MDCK细胞) · No verified English nameCXSL2300376 | Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/05/26New drug · Class 3.2 | 人纤溶酶原 · No verified English nameCXSL2300375 | Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized |
| 2023/05/26New drug · Class 1 | KQ-2003自体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300374 | Shanghai Ke Qi Pharma Technology Co., Ltd. romanized |
| 2023/05/26New drug · Class 1 | JY03注射液 · No verified English nameCXSL2300373 | Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized |
| 2023/05/26New drug · Class 1 | YH2000片 · No verified English nameCXHL2300580 | Wuhan Shi Jin Nuo Sai Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/25Import · Class 2.2; 2.1 | 佩索利单抗注射液(皮下注射) · No verified English nameJXSS2300039 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/05/25Import · Class 1 | Olorofim片 · No verified English nameJXHL2300123 | Shionogi & Co. Ltd.; Ping An-Shionogi Co. Ltd. |
| 2023/05/25Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2301414 | Anhui Shuang He Pharma Co., Ltd. romanized |
| 2023/05/25New drug · Class 3.1 | 济川颗粒 · No verified English nameCXZS2300011 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2023/05/25New drug · Class 3.3 | 吸附破伤风疫苗 · No verified English nameCXSL2300372 | Kang Xi Nuo Bio Shareholding Company romanized |
| 2023/05/25New drug · Class 1 | VC004胶囊 · No verified English nameCXHL2300579 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/25New drug · Class 1 | VC004胶囊 · No verified English nameCXHL2300578 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/05/24Generic · Class 3 | 聚乙二醇3350散 · No verified English nameCYHS2301409 | Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Tang Shan) Biopharmaceutical Co., Ltd. romanized |
| 2023/05/24Generic · Class 3 | Diprophylline InjectionCYHS2301408 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/24Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2301406 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/24Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2301405 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/05/24Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301404 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/24Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301403 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/24Generic · Class 3 | Oxacillin Sodium for InjectionCYHS2301402 | Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/24New drug · Class 3.3 | 帕妥珠单抗注射液 · No verified English nameCXSS2300038 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | 注射用BRII-877(VIR-3434) · No verified English nameCXSL2300371 | Teng Sheng Bo Yao Pharmaceuticals Technology (Beijing) Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | FT-003注射液 · No verified English nameCXSL2300370 | Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | RC148注射液 · No verified English nameCXSL2300369 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
58 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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