YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 336 drug applications between 14 July 2023 and 20 July 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 35 drug names.
2023/07/14 – 2023/07/20
- New acceptances this week
- 336
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 0
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
336filings, 52 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 175 |
| Generic | 52 |
| New drug | 50 |
| Import | 27 |
| Import re-registration | 20 |
| Unspecified | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| Therapeutic biologic | 44 |
| TCM | 43 |
| Prophylactic biologic | 4 |
| In vitro diagnostic reagent | 1 |
| 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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Hyaluronate Eye Drops | 3 | 2 | 30 |
| 2 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 3 | Vortioxetine Hydrobromide Tablets | 3 | 1 | 10 |
| 4 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 5 | 瑞巴派特片 · No verified English name | 2 | 2 | 4 |
| 6 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 2 | 2 | 8 |
| 7 | Acetylcysteine Granules | 2 | 1 | 4 |
| 8 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 9 | Piracetam Injection | 2 | 1 | 9 |
| 10 | Indobufen Tablets | 2 | 1 | 6 |
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
194 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized | 32 | 23 | 0 |
| 2 | AstraZeneca AB | 13 | 4 | 0 |
| 3 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 9 | 8 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 6 | 4 | 0 |
| 5 | Chengdu Di Yi Pharmaceutical Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | LGC GmbH | 3 | 3 | 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
87 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/07/20Import · Class 1 | MEDI5752 · No verified English nameJXSL2300131 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/07/20Import · Class 1 | Zipalertinib片 · No verified English nameJXHL2300171 | Taiho Oncology Inc.; Zai Lab (Shanghai) CO. Ltd. |
| 2023/07/20Generic · Class 3 | 聚乙二醇4000散(儿童型) · No verified English nameCYHS2301944 | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/20New drug · Class 2.3 | HYR04胶囊 · No verified English nameCXZL2300051 | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized |
| 2023/07/20New drug · Class 1.1 | 补肺益肾颗粒 · No verified English nameCXZL2300050 | Zhongguo Zhong Yi Ke College Zhong Yao Research Institute romanized; Hunan Sheng Zhong Pharmaceuticals Research Institute romanized |
| 2023/07/20New drug · Class 1 | 注射用MR001双特异性抗体 · No verified English nameCXSL2300497 | Shenzhen Shi Mai Jia Rui Bio Technology Co., Ltd. romanized |
| 2023/07/20New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2300802 | Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2023/07/20New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2300801 | Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized |
| 2023/07/20New drug · Class 1 | GLB-002胶囊 · No verified English nameCXHL2300800 | Hangzhou Ge Bo Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/20New drug · Class 1 | GLB-002胶囊 · No verified English nameCXHL2300799 | Hangzhou Ge Bo Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/19Generic · Class 3 | Minoxidil LinimentCYHS2301940 | Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/07/19Generic · Class 3 | Minoxidil LinimentCYHS2301939 | Hangzhou Min Sheng Health Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/07/19Generic · Class 3 | Piracetam InjectionCYHS2301938 | Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2023/07/19Generic · Class 3 | Piracetam InjectionCYHS2301937 | Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2023/07/19New drug · Class 1.1 | 双参宁心胶囊 · No verified English nameCXZL2300049 | Zhongguo Zhong Yi Ke College Xi Yuan Hospital romanized |
| 2023/07/19New drug · Class 1.1 | 小儿健脾颗粒 · No verified English nameCXZL2300048 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized |
| 2023/07/19New drug · Class 2.5 | 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSS2300054 | Changchun Zhuo Yi Bio Co., Ltd. romanized |
| 2023/07/19New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300053 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized |
| 2023/07/19New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSS2300052 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized; Suzhou Zhong He Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/07/19New drug · Class 1 | HH-006注射液 · No verified English nameCXSL2300496 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2023/07/19New drug · Class 3.3 | 四价流感病毒裂解疫苗 · No verified English nameCXSL2300495 | Zhejiang Tian Yuan Bio Pharma Co., Ltd. romanized |
| 2023/07/19New drug · Class 1 | SHR-2022注射液 · No verified English nameCXSL2300494 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/19New drug · Class 1 | SKG0106眼内注射溶液 · No verified English nameCXSL2300493 | Lan Yue Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2023/07/19New drug · Class 2.4 | Chidamide TabletsCXHS2300061 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized; Shenzhen Wei Xin Pharma Co., Ltd. romanized |
| 2023/07/19New drug · Class 1 | MT-001胶囊 · No verified English nameCXHL2300798 | Zhejiang Mai Tong Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/19New drug · Class 1 | MT-001胶囊 · No verified English nameCXHL2300797 | Zhejiang Mai Tong Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/19New drug · Class 1 | HYP-2090PTSA胶囊 · No verified English nameCXHL2300796 | Name not romanized |
| 2023/07/19New drug · Class 1 | 吸入用HTPEP-001 · No verified English nameCXHL2300795 | Chengdu Hui Tai Biopharmaceuticals Co., Ltd. romanized |
| 2023/07/18Import · Class 1 | HFB200301注射液 · No verified English nameJXSL2300130 | HiFiBiO Inc.; HiFiBiO (Hangzhou) Co. Ltd |
| 2023/07/18Import · Class 1 | AZD9833片 · No verified English nameJXHL2300170 | AstraZeneca AB; AstraZeneca Investment (China) Co. Limited |
57 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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