YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 413 drug applications between 18 May 2023 and 24 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 45 drug names.
2023/05/18 – 2023/05/24
- New acceptances this week
- 413
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- 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
413filings, 72 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 243 |
| Generic | 72 |
| New drug | 67 |
| Import re-registration | 16 |
| Import | 10 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 295 |
| TCM | 73 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 3 |
| 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Roxadustat Capsules | 8 | 4 | 17 |
| 2 | Naloxone Hydrochloride Injection | 4 | 2 | 1 |
| 3 | Ropivacaine hydrochloride injection | 4 | 1 | 5 |
| 4 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 5 | Carfilzomib For Injection | 3 | 1 | 0 |
| 6 | Oxacillin Sodium for Injection | 3 | 1 | 13 |
| 7 | Indobufen Tablets | 2 | 2 | 6 |
| 8 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 9 | Phloroglucinol Injection | 2 | 2 | 2 |
| 10 | Nicorandil for 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
193 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 37 | 36 | 0 |
| 2 | Hubei Lang De Pharma Co., Ltd. romanized | 34 | 16 | 0 |
| 3 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 24 | 11 | 0 |
| 4 | Ping Guang Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 5 | UCB Pharma SA | 6 | 1 | 0 |
| 6 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Guang Sheng Yuan Zhong Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
104 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2023/05/24New drug · Class 1 | BN104片 · No verified English nameCXHL2300577 | Ye Hui Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | BN104片 · No verified English nameCXHL2300576 | Ye Hui Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2300573 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2300572 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2300571 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2300570 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2300569 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | HTMC0435片 · No verified English nameCXHL2300568 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | ASC60片 · No verified English nameCXHL2300567 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2023/05/24New drug · Class 1 | ASC60片 · No verified English nameCXHL2300566 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Nicorandil for InjectionCYHS2301394 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Nicorandil for InjectionCYHS2301393 | Chongqing Lai Mei Pharma Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2301390 | Bai Shan Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Methocarbamol InjectionCYHS2301383 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Minoxidil Topical SolutionCYHS2301380 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301378 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301377 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2301371 | Nanjing Chuang Di Bio Technology Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2023/05/23Generic · Class 3 | Acetylcysteine Oral SolutionCYHS2301370 | Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) 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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