YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 377 drug applications between 13 August 2025 and 19 August 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 118, covering 80 drug names.
2025/08/13 – 2025/08/19
- New acceptances this week
- 377
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 106
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
377filings, 118 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 143 |
| Generic | 118 |
| New drug | 77 |
| Import | 21 |
| Unspecified | 15 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 250 |
| Therapeutic biologic | 63 |
| TCM | 53 |
| Biologic | 6 |
| Prophylactic biologic | 5 |
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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 4 | 2 | 70 |
| 2 | 卡格列净二甲双胍缓释片 · No verified English name | 4 | 1 | 5 |
| 3 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 4 | Bifonazole Solution | 3 | 3 | 15 |
| 5 | Baricitinib Tablets | 3 | 2 | 32 |
| 6 | Trazodone Hydrochloride Sustained-release Tablets | 3 | 2 | 20 |
| 7 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 3 | 1 | 7 |
| 8 | 中性腹膜透析液(碳酸氢盐-G2.5%) · No verified English name | 3 | 1 | 7 |
| 9 | Lactulose Oral Solution | 3 | 1 | 34 |
| 10 | Ruxolitinib Phosphate Tablets | 3 | 1 | 27 |
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
226 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 9 | 4 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 8 | 4 | 3 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 5 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 6 | 2 | 6 |
| 6 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED | 4 | 3 | 0 |
| 9 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | Bristol-Myers Squibb Pharma EEIG | 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
136 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/08/19Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2503045 | Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Xian Tong Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503040 | Le Pu Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503039 | Le Pu Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503038 | Le Pu Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | 卡格列净二甲双胍缓释片 · No verified English nameCYHS2503037 | Le Pu Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | Pralidoxime Chloride For InjectionCYHS2503035 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | Bifonazole SolutionCYHS2503029 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | Polaprezinc GranulesCYHS2503026 | Beijing Han Mei Medicines Co., Ltd. romanized |
| 2025/08/19Generic · Class 3 | Acetylcysteine GranulesCYHS2503020 | Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized |
| 2025/08/19New drug · Class 1.1 | 小儿连花清感颗粒 · No verified English nameCXZS2500034 | Shijiazhuang Yi Ling Pharma Co., Ltd. romanized |
| 2025/08/19New drug · Class 2.1; 2.3 | 盘龙七凝胶贴膏 · No verified English nameCXZL2500066 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | GKL-006RTU注射液 · No verified English nameCXSL2500721 | Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized |
| 2025/08/19New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSL2500720 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/08/19New drug · Class 2.2 | 重组人血小板生成素注射液 · No verified English nameCXSL2500719 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2500718 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | 注射用3H-10000 · No verified English nameCXSL2500717 | Si Kang Rui Qi (Shanghai) Pharma Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | HCB101注射液 · No verified English nameCXSL2500716 | Guangzhou Han Ke Bio Co., Ltd. romanized |
| 2025/08/19New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500715 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2500714 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | 注射用SHR-9839 (sc) · No verified English nameCXSL2500713 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500712 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500711 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2025/08/19New drug · Class 1.3 | 重组乙型肝炎疫苗(汉逊酵母,CpG和铝佐剂) · No verified English nameCXSL2500710 | Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized; Huan Ke (Hebei) Bio Technology Co., Ltd. romanized |
| 2025/08/19New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHS2500096 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | HRS-7058片 · No verified English nameCXHL2500876 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | HRS-7058片 · No verified English nameCXHL2500875 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2500874 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2500873 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/08/19New drug · Class 1 | CG-7321胶囊 · No verified English nameCXHL2500872 | Name not romanized |
| 2025/08/19New drug · Class 1 | CG-7321胶囊 · No verified English nameCXHL2500871 | Name not romanized |
106 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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