YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 370 drug applications between 13 October 2023 and 19 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 86, covering 59 drug names.
2023/10/13 – 2023/10/19
- New acceptances this week
- 370
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- 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
370filings, 86 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 86 |
| New drug | 59 |
| Import | 19 |
| Import re-registration | 6 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 82 |
| Therapeutic biologic | 49 |
| Prophylactic biologic | 5 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diquafosol Sodium Eye Drops | 4 | 3 | 5 |
| 2 | Famotidine Injection | 3 | 2 | 8 |
| 3 | 小儿复方氨基酸注射液(19AA-I) · No verified English name | 3 | 1 | 2 |
| 4 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 5 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 3 | 1 | 2 |
| 6 | Oseltamivir Phosphate For Oral Suspension | 3 | 1 | 2 |
| 7 | Diprophylline Injection | 2 | 2 | 7 |
| 8 | Ezetimibe Tablets | 2 | 2 | 4 |
| 9 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 10 | Compound Ipratropium Bromide Solution For Inhalation | 2 | 2 | 4 |
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
222 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 13 | 12 | 0 |
| 2 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 9 | 1 | 0 |
| 3 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized | 8 | 3 | 0 |
| 4 | Pfizer Europe MA EEIG | 6 | 4 | 0 |
| 5 | Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 6 | 3 | 6 |
| 6 | Guangxi Hong Ji Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Pfizer Inc. | 4 | 3 | 0 |
| 9 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 4 | 3 | 4 |
| 10 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/10/19Import · Class 2.1 | Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300187 | Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd. |
| 2023/10/19Import · Class 2.1 | Guselkumab Final Vialed Product for Intravenous Infusion (FVP(IV)) · No verified English nameJXSL2300186 | Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd. |
| 2023/10/19Import · Class 1 | LY3537982胶囊 · No verified English nameJXHL2300258 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/10/19Import · Class 1 | LY3537982胶囊 · No verified English nameJXHL2300257 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/10/19Import · Class 1 | RZL-012注射液 · No verified English nameJXHL2300256 | Raziel Therapeutics (RT) Ltd.; Tianjin Juvestar Biotech Co. Ltd. |
| 2023/10/19Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302807 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/10/19Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2302806 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/10/19Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2302805 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/10/19Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2302804 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/10/19Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2302803 | Shandong Jian Dao Pharmaceutical Co., Ltd. romanized |
| 2023/10/19New drug · Class 1 | 靶向磷脂酰肌醇蛋白多糖-3嵌合抗原受体修饰的自体T细胞注射液 · No verified English nameCXSL2300716 | Ke Ji Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2023/10/19New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300715 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2023/10/19New drug · Class 1 | 注射用LM-108 · No verified English nameCXSL2300714 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2023/10/19New drug · Class 1 | ZHB103注射液 · No verified English nameCXSL2300711 | Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized |
| 2023/10/19New drug · Class 2.2 | 注射用硼[10B]法仑 · No verified English nameCXHL2301125 | Zhong Peng (Xiamen) Biopharmaceuticals Co., Ltd. romanized |
| 2023/10/18Import · Class 1 | Sisunatovir 片 · No verified English nameJXHL2300255 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2023/10/18Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2302799 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Aminophylline InjectionCYHS2302798 | Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Calcium Acetate Oral SolutionCYHS2302797 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Acetylcysteine InjectionCYHS2302796 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized |
| 2023/10/18Generic · Class 3 | Diprophylline InjectionCYHS2302795 | Xizang Hai Jin Pharma Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | BD211自体CD34+造血干细胞注射液 · No verified English nameCXSL2300710 | Shanghai Ben Dao Ji Yin Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSL2300709 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSL2300708 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | Domvanalimab注射液 · No verified English nameCXSL2300707 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | Domvanalimab注射液 · No verified English nameCXSL2300706 | Ji Li De (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | Tinlarebant 片 · No verified English nameCXHL2301124 | Bei Liang Sheng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | TQB3909片 · No verified English nameCXHL2301123 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | TQB3909片 · No verified English nameCXHL2301122 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/10/18New drug · Class 1 | TQB3702片 · No verified English nameCXHL2301121 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
84 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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