YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 260 drug applications between 10 September 2022 and 16 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 55, covering 39 drug names.
2022/09/10 – 2022/09/16
- New acceptances this week
- 260
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- 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
260filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 147 |
| Generic | 55 |
| New drug | 33 |
| Import | 13 |
| Unspecified | 6 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 196 |
| TCM | 35 |
| Therapeutic biologic | 29 |
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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets | 5 | 1 | 0 |
| 2 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 3 | Cefotiam Hydrochloride For Injection | 3 | 1 | 0 |
| 4 | 复方聚乙二醇电解质散(Ⅲ) · No verified English name | 2 | 2 | 1 |
| 5 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 6 | Peramivir Injection | 2 | 1 | 7 |
| 7 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 8 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 9 | Minoxidil Liniment | 2 | 1 | 52 |
| 10 | Potassium Aspartate Injection | 2 | 1 | 3 |
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
153 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Jin Xing Industrial Co., Ltd. romanized | 10 | 6 | 0 |
| 2 | Shandong Kong Sheng Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | AstraZeneca AB | 5 | 3 | 0 |
| 5 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 7 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 5 |
| 8 | Hainan Mei Lan Shi Ke Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 4 | 4 | 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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/16Import · Class 1 | DS-1062a · No verified English nameJXSL2200166 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2022/09/16Generic · Class 3 | Piperacillin Sodium for InjectionCYHS2201550 | Hainan Zhong Yue Medical Health Industry Co., Ltd. romanized; Sichuan Pharmaceutical Formulations Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2201548 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2201547 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2201546 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201540 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201539 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201538 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201537 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Dapagliflozin And Metformin Hydrochloride Extended-Release TabletsCYHS2201536 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Tranexamic Acid InjectionCYHS2201532 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Tranexamic Acid InjectionCYHS2201531 | Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Brivaracetam Solution for InjectionCYHL2200079 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2022/09/16Generic · Class 3 | Rupatadine Fumarate Oral SolutionCYHL2200078 | Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/16New drug · Class 2.2 | 培集成干扰素α-2注射液 · No verified English nameCXSL2200464 | Beijing Kai Yin Technology Co., Ltd. romanized |
| 2022/09/16New drug · Class 3.3 | 达雷妥尤单抗注射液 · No verified English nameCXSL2200463 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/09/16New drug · Class 3.3 | 达雷妥尤单抗注射液 · No verified English nameCXSL2200462 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | 舒非尼酮(SC1011)凝胶 · No verified English nameCXHL2200689 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | 舒非尼酮(SC1011)凝胶 · No verified English nameCXHL2200688 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/16New drug · Class 2.2 | 优替德隆胶囊 · No verified English nameCXHL2200687 | Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/16New drug · Class 2.2 | 优替德隆胶囊 · No verified English nameCXHL2200686 | Chengdu Hua Hao Zhong Tian Pharma Co., Ltd. romanized; Beijing Hua Hao Zhong Tian Biopharmaceuticals Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | HJM-353片 · No verified English nameCXHL2200683 | He Jing Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | HJM-353片 · No verified English nameCXHL2200682 | He Jing Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | CGT-1967片 · No verified English nameCXHL2200681 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | CGT-1967片 · No verified English nameCXHL2200680 | Sheng Shi Tai Ke Biopharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | APG-2575片 · No verified English nameCXHL2200679 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2022/09/16New drug · Class 1 | APG-2575片 · No verified English nameCXHL2200678 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2022/09/15Import · Class 2.2 | 奥妥珠单抗注射液 · No verified English nameJXSL2200165 | F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/09/15Import · Class 1 | LY3819469注射液 · No verified English nameJXHL2200285 | Eli Lilly and Company |
| 2022/09/15Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2201528 | Jilin Si Zhang Pharmaceutical Co., Ltd. romanized |
46 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.