YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 469 drug applications between 3 August 2026 and 9 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 60 drug names.
2026/08/03 – 2026/08/09
- New acceptances this week
- 469
- Drugs with new generic filings (by drug name, de-duplicated)
- 60
- Accepted this week, now under review
- 212
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
469filings, 84 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 257 |
| Generic | 84 |
| New drug | 82 |
| Import | 36 |
| Unspecified | 6 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 207 |
| TCM | 176 |
| Therapeutic biologic | 83 |
| Prophylactic biologic | 2 |
| 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
60 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 替尔泊肽注射液 · No verified English name | 4 | 1 | 22 |
| 2 | Edaravone and Dexborneol Concentrated Solution for Injection | 3 | 3 | 34 |
| 3 | Ambroxol Hydrochloride Solution For Inhalation | 3 | 1 | 10 |
| 4 | Ixazomib Citrate Capsules | 3 | 1 | 7 |
| 5 | 鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name | 3 | 1 | 6 |
| 6 | Fluvastatin Sodium Extended Release Tablets | 2 | 2 | 6 |
| 7 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 8 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
| 9 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 1 | 23 |
| 10 | Cyclophosphamide for 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
263 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized | 18 | 17 | 0 |
| 2 | Eli Lilly and Company | 11 | 2 | 0 |
| 3 | Topfond Pharmaceutical Co., Ltd. | 6 | 6 | 0 |
| 4 | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bayer Inc. | 6 | 1 | 0 |
| 6 | Gilead Sciences Inc. | 6 | 1 | 0 |
| 7 | Li Zhu Group Li Min Pharmaceutical Factory romanized | 6 | 1 | 0 |
| 8 | Hubei Dong Xin Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | AbbVie Inc. | 5 | 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
144 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/08/07Import · Class 3.1 | 尼塞韦单抗注射液 · No verified English nameJXSS2600072 | Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd. |
| 2026/08/07Import · Class 3.1 | 尼塞韦单抗注射液 · No verified English nameJXSS2600071 | Sanofi Winthrop Industrie; Patheon Manufacturing Services LLC; Sanofi (China) Investment Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600331 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600330 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600329 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/07Generic · Class 3 | Ferrous Succinate TabletsCYHS2601935 | Anhui Zheng Yao Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/08/07Generic · Class 3 | Acetaminophen InjectionCYHS2601934 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2026/08/07Generic · Class 3 | Gatifloxacin Eye DropsCYHS2601932 | Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized |
| 2026/08/07Generic · Class 3 | Ropinirole Hydrochloride TabletsCYHS2601930 | Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized |
| 2026/08/07New drug · Class 3.1 | 当归六黄汤颗粒 · No verified English nameCXZS2600045 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/08/07New drug · Class 3.1 | 厚朴温中汤颗粒 · No verified English nameCXZS2600044 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/08/07New drug · Class 3.1 | 化肝煎颗粒 · No verified English nameCXZS2600043 | Shen Wei Pharma Group Co., Ltd. romanized |
| 2026/08/07New drug · Class 3.3 | 人生长激素注射液 · No verified English nameCXSS2600121 | Jun He Meng Biopharmaceutical (Hangzhou) Co., Ltd. romanized |
| 2026/08/07New drug · Class 3.3 | 人生长激素注射液 · No verified English nameCXSS2600120 | Jun He Meng Biopharmaceutical (Hangzhou) Co., Ltd. romanized |
| 2026/08/07New drug · Class 1 | SSGJ-718注射液 · No verified English nameCXSL2600847 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2026/08/07New drug · Class 1 | SSGJ-718注射液 · No verified English nameCXSL2600846 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2026/08/07New drug · Class 1 | IMC002注射液 · No verified English nameCXSL2600845 | Suzhou Yi Mu Feng Biopharmaceutical Co., Ltd. romanized; Shenzhen Yi Mu Feng Bio Technology Co., Ltd. romanized |
| 2026/08/07New drug · Class 1.2 | 鼻喷重组呼吸道合胞病毒疫苗(黑猩猩腺病毒载体) · No verified English nameCXSL2600844 | Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized |
| 2026/08/07New drug · Class 1 | 注射用MBS314 · No verified English nameCXSL2600843 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2026/08/07New drug · Class 1.1 | 冻干二价人类偏肺病毒mRNA疫苗 · No verified English nameCXSL2600842 | Wuhan Rui Ji Bio Technology Co., Ltd. romanized; Shenzhen Rui Ji Bio Technology Co., Ltd. romanized |
| 2026/08/07New drug · Class 1 | AP301胶囊 · No verified English nameCXHS2600115 | Li Bang Pharmaceutical (Yang Zhou) Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized |
| 2026/08/07New drug · Class 1 | S01D片 · No verified English nameCXHL2600976 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2026/08/07New drug · Class 1 | S01D片 · No verified English nameCXHL2600975 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2026/08/06Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600328 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/06Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600327 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/06Import · Class 1 | Edecesertib 片 · No verified English nameJXHL2600326 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/08/06Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2601919 | Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/08/06Generic · Class 3 | 琥珀酸索利那新口服混悬液 · No verified English nameCYHS2601913 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Beijing Zhao Yan Bio Technology Co., Ltd. romanized |
| 2026/08/06New drug · Class 2.1 | 万通筋骨巴布膏 · No verified English nameCXZS2600042 | Tong Hua Wan Tong Pharma Co., Ltd. romanized |
| 2026/08/06New drug · Class 1.1 | YJZ11031颗粒 · No verified English nameCXZL2600070 | Beijing Dong Fang Yun Jia Pharma Co., Ltd. romanized |
114 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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