YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 348 drug applications between 24 August 2023 and 30 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 58 drug names.
2023/08/24 – 2023/08/30
- New acceptances this week
- 348
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- 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
348filings, 74 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 74 |
| New drug | 52 |
| Import | 11 |
| Import re-registration | 8 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 235 |
| TCM | 66 |
| Therapeutic biologic | 40 |
| Prophylactic biologic | 6 |
| 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
58 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 3 | 1 | 23 |
| 2 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 3 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 4 | Methotrexate Injection | 2 | 2 | 11 |
| 5 | Oseltamivir Phosphate For Oral Suspension | 2 | 2 | 2 |
| 6 | Tacrolimus Ointment | 2 | 1 | 6 |
| 7 | Potassium Chloride Injection | 2 | 1 | 10 |
| 8 | Pemetrexed Disodium for Injection | 2 | 1 | 4 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 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 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 31 | 27 | 0 |
| 2 | Guizhou Rui He Pharmaceutical Co., Ltd. romanized | 23 | 23 | 0 |
| 3 | AstraZeneca AB | 7 | 3 | 0 |
| 4 | Celgene Corporation | 6 | 1 | 0 |
| 5 | GE Healthcare AS | 6 | 1 | 0 |
| 6 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 7 | Sanofi-Aventis Deutschland GmbH | 5 | 5 | 0 |
| 8 | Novartis Europharm Limited | 5 | 2 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 2 | 0 |
| 10 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 5 | 1 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/08/30Import · Class 1 | PF-06940434注射液 · No verified English nameJXSL2300159 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2023/08/30Generic · Class 3 | 盐酸丙卡特罗片 · No verified English nameCYHS2302320 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2023/08/30Generic · Class 3 | Pentoxifylline InjectionCYHS2302319 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Propranolol Hydrochloride InjectionCYHS2302310 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2302308 | Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2302307 | Chongqing Hua Bang Sheng Kai Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Mesalamine extended release capsulesCYHS2302305 | Beijing Foyou Pharma CO.,LTD |
| 2023/08/30Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2302304 | Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2302302 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2302299 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Nicorandil for InjectionCYHS2302298 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Nicorandil for InjectionCYHS2302297 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2023/08/30Generic · Class 3 | Calcium Gluconate InjectionCYHS2302296 | Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/08/30New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2300071 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
| 2023/08/30New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2300587 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/30New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSL2300586 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/08/30New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSL2300585 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/08/30New drug · Class 1 | 注射用IMM2510 · No verified English nameCXSL2300584 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/08/30New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2300583 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/08/30New drug · Class 1 | 注射用JSKN003 · No verified English nameCXSL2300582 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/08/30New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300581 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/08/30New drug · Class 1 | 吡罗西尼片 · No verified English nameCXHS2300075 | Xuan Zhu Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2023/08/30New drug · Class 2.2 | 盐酸氨溴索口服冻干片 · No verified English nameCXHL2300926 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. |
| 2023/08/30New drug · Class 2.2 | 盐酸氨溴索口服冻干片 · No verified English nameCXHL2300925 | China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd. |
| 2023/08/29Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300072 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2023/08/29Import · Class 3.1 | 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300071 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2023/08/29Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2302293 | Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2023/08/29Generic · Class 3 | Fludeoxyglucose[18F] InjectionCYHS2302290 | Guangdong Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized |
| 2023/08/29Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2302289 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2023/08/29New drug · Class 2.3 | 桑枝总生物碱片 · No verified English nameCXZL2300054 | Beijing Wu He Bo Ao Pharma Co., Ltd. romanized |
59 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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