YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 388 drug applications between 3 February 2023 and 9 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 119, covering 88 drug names.
2023/02/03 – 2023/02/09
- New acceptances this week
- 388
- Drugs with new generic filings (by drug name, de-duplicated)
- 88
- 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
388filings, 119 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 173 |
| Generic | 119 |
| New drug | 73 |
| Import | 14 |
| Import re-registration | 5 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 281 |
| Therapeutic biologic | 59 |
| TCM | 47 |
| Prophylactic 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
88 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Potassium Chloride Granules | 4 | 3 | 4 |
| 2 | Phenylephrine Hydrochloride Injection | 4 | 2 | 5 |
| 3 | Calcium Levofolinate Injection | 4 | 1 | 0 |
| 4 | Oxaliplatin Injection | 3 | 2 | 4 |
| 5 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 3 | 1 | 12 |
| 6 | Amoxicillin Sodium for Injection | 3 | 1 | 0 |
| 7 | Indobufen Tablets | 2 | 2 | 6 |
| 8 | Tropicamide Phenylephrine Eye Drops | 2 | 2 | 8 |
| 9 | Mecobalamin Tablets | 2 | 2 | 16 |
| 10 | Lactulose Oral Solution | 2 | 1 | 34 |
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
240 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Yunnan Shen Wei Shi Pu Rui Pharma Co., Ltd. romanized | 15 | 15 | 0 |
| 2 | Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 6 | 6 |
| 3 | Run Yuan Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Lu Nan Hou Pu Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | Anhui Pioneer Pharmaceutical Co., Ltd | 6 | 2 | 0 |
| 6 | Guangxi Yu Yuan Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 3 | 3 |
| 10 | Shenyang Jun Yuan Pharma 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
131 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/09Import · Class 3.1 | Aducanumab 注射液 · No verified English nameJXSL2300036 | Biogen Inc.; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2023/02/09Import · Class 2.2 | Ravulizumab注射液 · No verified English nameJXSL2300035 | Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/02/09Generic · Class 3 | Indobufen TabletsCYHS2300426 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized |
| 2023/02/09Generic · Class 3 | Scopolamine Butylbromide InjectionCYHS2300424 | Xiamen Zi Xu Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2023/02/09Generic · Class 3 | L-Arginine L-Glutamate Hydrate InjectionCYHS2300419 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
| 2023/02/09Generic · Class 3 | Potassium Chloride GranulesCYHS2300415 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2023/02/09Generic · Class 3 | Potassium Chloride GranulesCYHS2300414 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2023/02/09Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2300413 | Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized |
| 2023/02/09Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2300411 | Nanjing Si Tai Er Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Shen Long Pharma Co., Ltd. romanized |
| 2023/02/09Generic · Class 3 | Nicorandil for InjectionCYHS2300408 | YaoPharma Co., Ltd. |
| 2023/02/09New drug · Class 1.1 | 荆门上清丸 · No verified English nameCXZS2300005 | Hubei Qi Jin Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Xiang Yang) Long Zhong Co., Ltd. romanized |
| 2023/02/09New drug · Class 1.2 | 白头翁皂苷B4栓 · No verified English nameCXZL2300009 | Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized |
| 2023/02/09New drug · Class 1.2 | 白头翁皂苷B4 · No verified English nameCXZL2300008 | Jiangxi Zhong Pharmaceuticals University romanized; Guangxi Xin Hai Pharma Technology Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | SHR-2106注射液 · No verified English nameCXSL2300113 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | 注射用TQB2103 · No verified English nameCXSL2300112 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | GSK4381562A注射液 · No verified English nameCXSL2300111 | Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized |
| 2023/02/09New drug · Class 3.3 | 达雷妥尤单抗注射液 · No verified English nameCXSL2300110 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | NCR300注射液 · No verified English nameCXSL2300109 | Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized |
| 2023/02/09New drug · Class 3.3 | 达雷妥尤单抗注射液 · No verified English nameCXSL2300108 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | FT-003注射液 · No verified English nameCXSL2300107 | Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | FT-003注射液 · No verified English nameCXSL2300106 | Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized |
| 2023/02/09New drug · Class 2.2 | 重组人截短型纤溶酶注射液 · No verified English nameCXSL2300105 | Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized |
| 2023/02/09New drug · Class 2.2 | 卡度尼利单抗注射液 · No verified English nameCXSL2300104 | Kang Fang Pharma Co., Ltd. romanized |
| 2023/02/09New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300103 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2023/02/09New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2300102 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | 注射用AMT-151 · No verified English nameCXSL2300101 | Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | BBM-H803注射液 · No verified English nameCXSL2300100 | Shanghai Xin Zhi Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Mian Yi Bio Technology Co., Ltd. romanized |
| 2023/02/09New drug · Class 1 | AK117注射液 · No verified English nameCXSL2300099 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2023/02/09New drug · Class 2.2 | 卡度尼利单抗注射液 · No verified English nameCXSL2300098 | Kang Fang Pharma Co., Ltd. romanized |
| 2023/02/09New drug · Class 2.4 | Edaravone and Dexborneol Concentrated Solution for InjectionCXHL2300190 | Xian Sheng Pharma Co., Ltd. romanized |
101 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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