YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 254 drug applications between 13 March 2022 and 19 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 21, covering 15 drug names.
2022/03/13 – 2022/03/19
- New acceptances this week
- 254
- Drugs with new generic filings (by drug name, de-duplicated)
- 15
- 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
254filings, 21 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| New drug | 25 |
| Generic | 21 |
| Unspecified | 16 |
| Import | 14 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| Therapeutic biologic | 36 |
| TCM | 23 |
| Prophylactic biologic | 7 |
| Biologic | 6 |
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
15 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Paliperidone Palmitate Injection | 3 | 1 | 8 |
| 2 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 3 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 4 | Pregabalin Capsules | 2 | 1 | 12 |
| 5 | Febuxostat Tablets | 2 | 1 | 12 |
| 6 | 布南色林片 · No verified English name | 1 | 1 | 0 |
| 7 | Amlodipine Besylate and Atorvastatin Calcium Tablets | 1 | 1 | 2 |
| 8 | Nicorandil for Injection | 1 | 1 | 1 |
| 9 | Regorafenib Tablets | 1 | 1 | 3 |
| 10 | Trimetazidine Dihydrochloride Tablets | 1 | 1 | 0 |
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
132 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized | 17 | 15 | 0 |
| 2 | Jilin Sheng Dou Bang Pharma Co., Ltd. romanized | 14 | 2 | 0 |
| 3 | Zhejiang Dou Bang Pharma Co., Ltd. romanized | 12 | 2 | 0 |
| 4 | Novo Nordisk A/S | 8 | 3 | 0 |
| 5 | Sanofi -aventis France | 7 | 1 | 0 |
| 6 | Hainan Xu Wo Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 7 | Kyowa Kirin Co. Ltd. | 6 | 1 | 0 |
| 8 | PURISYS LLC. | 5 | 5 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 5 | 2 | 3 |
| 10 | Celgene Corporation | 4 | 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
38 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/03/18Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2200459 | Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2022/03/18Generic · Class 3 | Sodium Valproate Concentrated Solution for InjectionCYHS2200458 | Guangdong Jiu Rui Technology Kai Fa Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized |
| 2022/03/18New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSL2200132 | Guangzhou Yu Heng Bio Technology Co., Ltd. romanized |
| 2022/03/18New drug · Class 1 | AND017胶囊 · No verified English nameCXHL2200165 | Hangzhou An Dao Pharma Co., Ltd. romanized |
| 2022/03/18New drug · Class 1 | AND017胶囊 · No verified English nameCXHL2200164 | Hangzhou An Dao Pharma Co., Ltd. romanized |
| 2022/03/18New drug · Class 1 | AND017胶囊 · No verified English nameCXHL2200163 | Hangzhou An Dao Pharma Co., Ltd. romanized |
| 2022/03/17Import · Class 3.1 | 注射用Tafasitamab · No verified English nameJXSL2200031 | Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd. |
| 2022/03/17Import · Class 2.4 | Inclisiran注射液 · No verified English nameJXHL2200061 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/03/17Import · Class 2.4 | Alectinib Hydrochloride CapsulesJXHL2200060 | F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2022/03/17Import · Class 2.4 | Entrectinib胶囊 · No verified English nameJXHL2200059 | F.Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd. |
| 2022/03/17Import · Class 2.4 | Entrectinib胶囊 · No verified English nameJXHL2200058 | F. Hoffmann-La Roche Ltd.; Roche(China)Holding Ltd. |
| 2022/03/17Generic · Class 3 | Minoxidil LinimentCYHS2200456 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/03/17New drug · Class 1.1 | 小儿香薷颗粒 · No verified English nameCXZL2200015 | Yi Li Pharmaceutical Co., Ltd. romanized |
| 2022/03/17New drug · Class 1 | MW11注射液 · No verified English nameCXSL2200128 | Sheng Sen Biopharmaceutical Co., Ltd. romanized |
| 2022/03/17New drug · Class 1 | 盐酸凯普拉生注射液 · No verified English nameCXHL2200166 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized |
| 2022/03/16Generic · Class 3 | Nicorandil for InjectionCYHS2200455 | Yunnan Xian Shi Pharma Co., Ltd. romanized; An Shi Pharmaceutical (Zhong Shan) Co., Ltd. romanized |
| 2022/03/16New drug · Class 3.3 | ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2200129 | Liaoning Cheng Da Bio Co., Ltd. romanized; Beijing Cheng Da Tian He Bio Technology Co., Ltd. romanized; Cheng Da Bio (Ben Xi) Co., Ltd. romanized |
| 2022/03/16New drug · Class 1 | 注射用ASK0912 · No verified English nameCXHL2200157 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized |
| 2022/03/15Import · Class 1 | GSK3196165 注射液 · No verified English nameJXSL2200030 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2022/03/15Import · Class 1 | GSK3196165 注射液 · No verified English nameJXSL2200029 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2022/03/15New drug · Class 3.3 | 23价肺炎球菌多糖疫苗 · No verified English nameCXSS2200028 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2022/03/15New drug · Class 2.2 | 赛帕利单抗注射液 · No verified English nameCXSS2200025 | Guangzhou Yu Heng Bio Technology Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2022/03/15New drug · Class 2.2 | HY-100209口崩片 · No verified English nameCXHL2200162 | Hefei Yi Gong Pharmaceuticals Co., Ltd. romanized |
| 2022/03/14Import · Class 1 | LY3209590注射液 · No verified English nameJXSL2200027 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/03/14Import · Class 1 | AZD2936 · No verified English nameJXSL2200026 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/03/14New drug · Class 2.2 | 贝那鲁肽注射液 · No verified English nameCXSS2200027 | Shanghai Ren Hui Biopharmaceutical Co., Ltd. romanized |
| 2022/03/14New drug · Class 2.2 | 贝那鲁肽注射液 · No verified English nameCXSS2200026 | Shanghai Ren Hui Biopharmaceutical Co., Ltd. romanized |
| 2022/03/14New drug · Class 1 | QX008N注射液 · No verified English nameCXSL2200127 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2022/03/14New drug · Class 1 | QX008N注射液 · No verified English nameCXSL2200126 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2022/03/14New drug · Class 1 | 重组人GM-CSF 溶瘤II型单纯疱疹病毒(OH2)注射液(Vero 细胞) · No verified English nameCXSL2200125 | Wuhan Bin Hui Bio Technology Co., Ltd. Bio Innovation Yuan Branch romanized |
8 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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