YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 298 drug applications between 26 July 2022 and 1 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 45 drug names.
2022/07/26 – 2022/08/01
- New acceptances this week
- 298
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- 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
298filings, 63 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 63 |
| New drug | 32 |
| Import | 14 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 211 |
| TCM | 56 |
| Therapeutic biologic | 25 |
| 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Urapidil Hydrochloride Injection | 4 | 2 | 6 |
| 2 | Galantamine Hydrobromide Orally Disintegrating Tablets | 3 | 1 | 0 |
| 3 | 二甲双胍恩格列净片(Ⅰ) · No verified English name | 2 | 2 | 7 |
| 4 | Olopatadine Hydrochloride Eye Drops | 2 | 2 | 13 |
| 5 | Nifuratel And Nystatin Vaginal Soft Capsules | 2 | 2 | 2 |
| 6 | Propofol Medium And Long Chain Fat Emulsion Injection | 2 | 1 | 3 |
| 7 | Paracetamol Suppositories | 2 | 1 | 0 |
| 8 | Ibuprofen Injection | 2 | 1 | 8 |
| 9 | Empagliflozin Tablets | 2 | 1 | 18 |
| 10 | Trifluridine and Tipiracil Hydrochloride Tablets | 2 | 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
153 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Dong Ling Pharma Technology (Liaoning) Co., Ltd. romanized | 37 | 36 | 0 |
| 2 | Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized | 22 | 16 | 0 |
| 3 | Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | Hebei Wu Luo Pharma Co., Ltd. romanized | 9 | 7 | 0 |
| 5 | Jilin Te Yan Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 5 | 5 | 3 |
| 7 | AstraZeneca UK Limited | 4 | 1 | 0 |
| 8 | Boehringer Ingelheim International GmbH | 4 | 1 | 0 |
| 9 | Le Tai Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Zhu Zhou Qian Jin Pharma Co., Ltd. romanized | 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
66 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/01Import · Class 1 | BI 1015550 片 · No verified English nameJXHL2200219 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/08/01Import · Class 1 | BI 1015550 片 · No verified English nameJXHL2200218 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/08/01Generic · Class 3 | Diazoxide Oral SuspensionCYHS2201199 | Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2022/08/01Generic · Class 3 | Paracetamol SuppositoriesCYHS2201185 | Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2022/08/01Generic · Class 3 | Paracetamol SuppositoriesCYHS2201184 | Zhejiang Er Ying Medicines Co., Ltd. romanized; Zhejiang Jian Feng Pharma Co., Ltd. romanized |
| 2022/08/01Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201181 | Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/08/01Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2201180 | Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/08/01New drug · Class 3.3 | 精蛋白锌赖脯胰岛素混合注射液(50R) · No verified English nameCXSS2200071 | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized |
| 2022/08/01New drug · Class 3.3 | 精蛋白锌赖脯胰岛素混合注射液(25R) · No verified English nameCXSS2200070 | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized |
| 2022/08/01New drug · Class 1 | 普那利单抗注射液 · No verified English nameCXSL2200348 | Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2022/08/01New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2200347 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2022/08/01New drug · Class 1 | HEC138671片 · No verified English nameCXHL2200546 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/08/01New drug · Class 1 | HEC138671片 · No verified English nameCXHL2200545 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2022/07/29Import · Class 3.1 | 注射用艾夫糖苷酶α · No verified English nameJXSS2200029 | Genzyme Corporation; Genzyme Ireland Limited; Sanofi (China) Investment Co. Ltd. |
| 2022/07/29Import · Class 3.1 | 人轮状病毒减毒活疫苗 · No verified English nameJXSL2200131 | GlaxoSmithKline Biologicals S.A. |
| 2022/07/29Generic · Class 3 | Ozagrel Sodium InjectionCYHS2201170 | Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2022/07/29Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2201169 | Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Ji Zhou) Co., Ltd. romanized |
| 2022/07/29Generic · Class 3 | Mesalazine Enteric-coated TabletsCYHS2201167 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2022/07/29Generic · Class 3 | 维生素B12滴眼液 · No verified English nameCYHS2201153 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2022/07/29New drug · Class 1 | TUL01101软膏 · No verified English nameCXHL2200544 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2022/07/29New drug · Class 1 | TUL01101软膏 · No verified English nameCXHL2200543 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2022/07/29New drug · Class 1 | TUL01101软膏 · No verified English nameCXHL2200542 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2022/07/28Import · Class 3.1 | ACYW群脑膜炎球菌多糖结合疫苗 · No verified English nameJXSL2200130 | Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd. |
| 2022/07/28Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2201160 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2022/07/28Generic · Class 3 | Sodium cromoglicate solution for inhalationCYHS2201159 | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2022/07/28New drug · Class 1 | 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200345 | Chengdu Ke En Bio Technology Co., Ltd. romanized |
| 2022/07/28New drug · Class 1 | 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200344 | Chengdu Ke En Bio Technology Co., Ltd. romanized |
| 2022/07/28New drug · Class 1 | 重组结核杆菌融合蛋白(EEC) · No verified English nameCXSL2200343 | Chengdu Ke En Bio Technology Co., Ltd. romanized |
| 2022/07/28New drug · Class 2.2 | 冻干人用狂犬病疫苗(无血清Vero细胞) · No verified English nameCXSL2200342 | Ningbo Rong An Bio Pharma Co., Ltd. romanized |
| 2022/07/28New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2200341 | Shanghai Quan Sheng Bio Technology Co., Ltd. romanized |
36 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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