YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 304 drug applications between 18 June 2022 and 24 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 33 drug names.
2022/06/18 – 2022/06/24
- New acceptances this week
- 304
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
304filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 176 |
| Generic | 48 |
| New drug | 36 |
| Import | 22 |
| Unspecified | 12 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 199 |
| TCM | 47 |
| Therapeutic biologic | 47 |
| Biologic | 9 |
| Prophylactic biologic | 2 |
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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普米司特片 · No verified English name | 4 | 2 | 3 |
| 2 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 3 | Venlafaxine Hydrochloride Sustained-Release Capsules | 3 | 1 | 0 |
| 4 | Dopamine Hydrochloride Injection | 2 | 2 | 3 |
| 5 | Acetylcysteine Granules | 2 | 1 | 4 |
| 6 | Elagolix Tablets | 2 | 1 | 2 |
| 7 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 8 | Levetiracetam Tablets | 2 | 1 | 6 |
| 9 | Aminocaproic Acid Injection | 2 | 1 | 0 |
| 10 | Esomeprazole Magnesium Enteric-Coated Capsules | 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 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized | 19 | 15 | 0 |
| 2 | Henan Tong Yuan Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 7 | 7 | 0 |
| 4 | Hubei Hua Hong Pharmaceuticals Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Janssen Research & Development LLC | 7 | 4 | 0 |
| 6 | Aspen Pharma Trading Limited | 7 | 2 | 0 |
| 7 | GlaxoSmithKline Biologicals SA | 4 | 4 | 0 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Chengdu Brilliant Pharmaceutical Co., Ltd. | 4 | 2 | 2 |
| 10 | McNeil Sweden AB | 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
70 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/24Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200949 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2022/06/24Generic · Class 3 | Piracetam InjectionCYHS2200948 | Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized |
| 2022/06/24Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2200947 | Hainan Wan Wei Pharmaceutical Co., Ltd. romanized |
| 2022/06/24Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2200943 | Zhejiang Yong Tai Pharma Co., Ltd. romanized |
| 2022/06/24Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2200941 | Zhejiang Yong Tai Pharma Co., Ltd. romanized |
| 2022/06/24New drug · Class 1 | IMM40H注射液 · No verified English nameCXSL2200293 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/06/24New drug · Class 1 | KM1溶瘤痘苗病毒注射液 · No verified English nameCXSL2200292 | Shenzhen Shi Hua Yao Kang Ming Bio Pharma Co., Ltd. romanized |
| 2022/06/24New drug · Class 1 | NCR100注射液 · No verified English nameCXSL2200291 | Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized |
| 2022/06/23Import · Class 3.1 | 注射用Teduglutide · No verified English nameJXSS2200021 | Takeda Pharmaceuticals International AG Ireland Branch; Patheon Italia S.p.A. |
| 2022/06/23Import · Class 2.2 | 贝利尤单抗注射液(皮下注射) · No verified English nameJXSL2200094 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2022/06/23Import · Class 1 | BI 764198胶囊 · No verified English nameJXHL2200161 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/06/23Import · Class 1 | BI 764198胶囊 · No verified English nameJXHL2200160 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/06/23Import · Class 1 | BI 764198胶囊 · No verified English nameJXHL2200159 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2022/06/23Import · Class 2.4 | Belzutifan片 · No verified English nameJXHL2200158 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D(China)Co. Ltd. |
| 2022/06/23Generic · Class 3 | Carglumic Acid Dispersible TabletsCYHS2200940 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
| 2022/06/23Generic · Class 3 | Furosemide Oral SolutionCYHS2200938 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2022/06/23Generic · Class 3 | Citicoline Sodium InjectionCYHS2200933 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2022/06/23Generic · Class 3 | 维A酸软胶囊 · No verified English nameCYHS2200932 | Shandong Liang Fu Pharmaceutical Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | LM-102注射液 · No verified English nameCXSL2200290 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2200289 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | 重组抗IL-17A人源化单克隆抗体注射液 · No verified English nameCXSL2200288 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2022/06/23New drug · Class 2.2 | 恩沃利单抗注射液 · No verified English nameCXSL2200287 | Sichuan Si Lu Kang Rui Pharma Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2200286 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | JX7002注射液 · No verified English nameCXSL2200264 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2022/06/23New drug · Class 1 | TQ-B3101胶囊 · No verified English nameCXHS2200035 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | TQ-B3101胶囊 · No verified English nameCXHS2200034 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | MN-08片 · No verified English nameCXHL2200413 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2022/06/23New drug · Class 1 | WXSH0208片 · No verified English nameCXHL2200412 | CISEN PHARMACEUTICAL CO., LTD. |
| 2022/06/23New drug · Class 1 | WXSH0208片 · No verified English nameCXHL2200411 | CISEN PHARMACEUTICAL CO., LTD. |
| 2022/06/23New drug · Class 2.2 | 注射用SAK2001 · No verified English nameCXHL2200410 | Hui Yu Kang Cheng (Hangzhou) Pharmaceuticals Technology Co., Ltd. romanized |
40 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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