YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 339 drug applications between 26 October 2023 and 1 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 52 drug names.
2023/10/26 – 2023/11/01
- New acceptances this week
- 339
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- 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
339filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 179 |
| Generic | 68 |
| New drug | 63 |
| Unspecified | 11 |
| Import re-registration | 10 |
| Import | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 64 |
| Therapeutic biologic | 40 |
| Biologic | 7 |
| Prophylactic biologic | 4 |
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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Piracetam Injection | 4 | 2 | 9 |
| 2 | Perindopril tert-Butylamine Tablets | 3 | 1 | 5 |
| 3 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 4 | Betamethasone Sodium Phosphate Injection | 2 | 1 | 5 |
| 5 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 6 | Doxofylline Tablets | 2 | 1 | 2 |
| 7 | Lacosamide Tablets | 2 | 1 | 0 |
| 8 | Trifluridine and Tipiracil Hydrochloride Tablets | 2 | 1 | 0 |
| 9 | Potassium Chloride Granules | 2 | 1 | 4 |
| 10 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 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
178 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 28 | 9 | 0 |
| 2 | Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized | 21 | 20 | 0 |
| 3 | Hebei Yu Zhi Lin Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Jin He Zang Yao Co., Ltd. romanized | 7 | 6 | 0 |
| 5 | Janssen-Cilag International NV | 7 | 4 | 0 |
| 6 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Li Bang Pharma (Shanghai) Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Shanghai Bio Zhi Pin Research Institute 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/01Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2302971 | Hong He Pharmaceutical Co., Ltd. romanized; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized |
| 2023/11/01Generic · Class 3 | Potassium Chloride GranulesCYHS2302961 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2023/11/01Generic · Class 3 | Potassium Chloride GranulesCYHS2302960 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2023/11/01Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2302959 | Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized |
| 2023/11/01Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300132 | Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized |
| 2023/11/01New drug · Class 1.1 | 松针正脑颗粒 · No verified English nameCXZL2300067 | Shenzhen Li Fu Bio Technology Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300747 | Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized |
| 2023/11/01New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300746 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | GRK-008片 · No verified English nameCXHL2301205 | Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/01New drug · Class 2.2 | LPC-007口溶膜 · No verified English nameCXHL2301204 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/11/01New drug · Class 2.2 | 奥曲肽长效注射液 · No verified English nameCXHL2301203 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/11/01New drug · Class 2.2 | 奥曲肽长效注射液 · No verified English nameCXHL2301202 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2301201 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2301200 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2301199 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | CSCJC3456片 · No verified English nameCXHL2301198 | Chang Shan Kai Jie Jian Bio Drug Research and Development (Hebei) Co., Ltd. romanized; Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | CSCJC3456片 · No verified English nameCXHL2301197 | Chang Shan Kai Jie Jian Bio Drug Research and Development (Hebei) Co., Ltd. romanized; Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | MY004567片 · No verified English nameCXHL2301196 | Wuhan Lang Lai Technology Development Co., Ltd. romanized |
| 2023/11/01New drug · Class 1 | MY004567片 · No verified English nameCXHL2301195 | Wuhan Lang Lai Technology Development Co., Ltd. romanized |
| 2023/10/31Import · Class 1 | Donanemab注射液 · No verified English nameJXSS2300082 | Eli Lilly and Company; Lilly France; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/10/31Import · Class 3.1 | 罗泽利昔珠单抗注射液 · No verified English nameJXSS2300081 | UCB Inc.; Vetter Pharma-Fertigung GmbH & Co. KG; UCB Trading (Shanghai) Co. Ltd |
| 2023/10/31Import · Class 2.4 | 卡巴胆碱滴眼液 · No verified English nameJXHL2300269 | Visus Therapeutics Inc.; Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Co. Ltd. |
| 2023/10/31Import · Class 2.4 | Sotorasib 片 · No verified English nameJXHL2300268 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2023/10/31Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2302956 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/10/31Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2302955 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/10/31Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2302952 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/10/31Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2302950 | Nanjing Chuang Di Bio Technology Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2023/10/31Generic · Class 3 | Diprophylline InjectionCYHS2302949 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2023/10/31Generic · Class 3 | Calcium Acetate CapsulesCYHS2302948 | Niu Ha Bo Pharma Co., Ltd. romanized |
| 2023/10/31Generic · Class 3 | Doxofylline TabletsCYHS2302945 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
70 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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