YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 416 drug applications between 3 December 2025 and 9 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 67 drug names.
2025/12/03 – 2025/12/09
- New acceptances this week
- 416
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 120
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
416filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 183 |
| Generic | 95 |
| New drug | 83 |
| Import | 25 |
| Unspecified | 15 |
| Import re-registration | 15 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 233 |
| TCM | 104 |
| Therapeutic biologic | 58 |
| Biologic | 13 |
| In vitro diagnostic reagent | 4 |
| Prophylactic biologic | 4 |
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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Finerenone Tablets | 5 | 3 | 69 |
| 2 | Minoxidil Liniment | 3 | 2 | 52 |
| 3 | Norepinephrine Bitartrate Injection | 3 | 2 | 9 |
| 4 | Riociguat Tablets | 3 | 1 | 4 |
| 5 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 3 | 1 | 12 |
| 6 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 7 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 8 | Tadalafil Tablets | 2 | 1 | 23 |
| 9 | 多种微量元素注射液(IV) · No verified English name | 2 | 1 | 4 |
| 10 | 奥洛他定莫米松鼻喷雾剂 · No verified English name | 2 | 1 | 1 |
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
242 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fu Song Xian Zhong Yao Co., Ltd. romanized | 30 | 30 | 0 |
| 2 | Eli Lilly and Company | 12 | 1 | 0 |
| 3 | Ai Min Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 5 |
| 6 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 7 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 8 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized | 4 | 4 | 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
146 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/09Import · Class 3.1 | ACYW群脑膜炎球菌多糖结合疫苗 · No verified English nameJXSL2500237 | Sanofi Pasteur Inc.; Shenzhen Sanofi Pasteur Biological Products Co. Ltd. |
| 2025/12/09Generic · Class 3 | Protamine Sulfate InjectionCYHS2504227 | Nanjing Hai Chen Pharma Co., Ltd. romanized |
| 2025/12/09Generic · Class 3 | Indobufen TabletsCYHS2504226 | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized |
| 2025/12/09Generic · Class 3 | 头孢克肟干混悬剂 · No verified English nameCYHS2504225 | Zhejiang Pu Luo Ju Tai Pharma Co., Ltd. romanized |
| 2025/12/09Generic · Class 3 | Minoxidil LinimentCYHS2504222 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2025/12/09Generic · Class 3 | Minoxidil LinimentCYHS2504221 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized |
| 2025/12/09Generic · Class 3 | 头孢克肟胶囊 · No verified English nameCYHS2504217 | Shandong Cheng Kang Pharma Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2025/12/09Generic · Class 3 | Bucladesine Sodium InjectionCYHL2500218 | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized |
| 2025/12/09Generic · Class 3 | Methylergonovine Maleate InjectionCYHL2500217 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2025/12/09New drug · Class 1.1 | 苏辛通窍颗粒 · No verified English nameCXZS2500051 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2025/12/09New drug · Class 3.2 | 人抗凝血酶III · No verified English nameCXSS2500136 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized |
| 2025/12/09New drug · Class 1 | YOLT-203注射液 · No verified English nameCXSL2501065 | Shanghai Yao Tang Bio Technology Co., Ltd. romanized |
| 2025/12/09New drug · Class 1 | IMM0306 · No verified English nameCXSL2501063 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/09New drug · Class 2.2 | 托莱西单抗注射液 · No verified English nameCXSL2501062 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/12/09New drug · Class 2.2 | IBI310 · No verified English nameCXSL2501061 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2025/12/09New drug · Class 1 | sbk002片 · No verified English nameCXHS2500153 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized; HAINAN HUALON PHARMACEUTICAL CO.,LTD |
| 2025/12/09New drug · Class 1 | JAB-23E73片 · No verified English nameCXHL2501348 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2025/12/09New drug · Class 1 | JAB-23E73片 · No verified English nameCXHL2501347 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2025/12/09New drug · Class 1 | JAB-23E73片 · No verified English nameCXHL2501346 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2025/12/08Generic · Class 3 | 左羟丙哌嗪糖浆 · No verified English nameCYHS2504213 | Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2025/12/08Generic · Class 3 | 左羟丙哌嗪糖浆 · No verified English nameCYHS2504212 | Hubei Wei Sen Pharmaceutical Co., Ltd. romanized |
| 2025/12/08Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2504211 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/08New drug · Class 3.1 | 温经汤颗粒 · No verified English nameCXZS2500050 | Shandong Run Zhong Pharma Co., Ltd. romanized |
| 2025/12/08New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSL2501060 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | 靶向BCMA的嵌合抗原受体T细胞注射液 · No verified English nameCXSL2501059 | Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized |
| 2025/12/08New drug · Class 3.3 | 重组抗CD38全人单克隆抗体注射液-皮下注射 · No verified English nameCXSL2501058 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2025/12/08New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2501057 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2501056 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | SYS6023 · No verified English nameCXSL2501055 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2025/12/08New drug · Class 1 | MRG006A · No verified English nameCXSL2501054 | Le Pu Bio Technology Co., Ltd. romanized |
116 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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