YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 420 drug applications between 4 December 2025 and 10 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 90, covering 66 drug names.
2025/12/04 – 2025/12/10
- New acceptances this week
- 420
- Drugs with new generic filings (by drug name, de-duplicated)
- 66
- Accepted this week, now under review
- 121
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
420filings, 90 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 182 |
| Generic | 90 |
| New drug | 88 |
| Import | 28 |
| Unspecified | 16 |
| Import re-registration | 16 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 250 |
| TCM | 93 |
| Therapeutic biologic | 54 |
| Biologic | 13 |
| Prophylactic biologic | 6 |
| In vitro diagnostic reagent | 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
66 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 | 多种微量元素注射液(IV) · No verified English name | 2 | 1 | 4 |
| 8 | 奥洛他定莫米松鼻喷雾剂 · No verified English name | 2 | 1 | 1 |
| 9 | 左羟丙哌嗪糖浆 · No verified English name | 2 | 1 | 0 |
| 10 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
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
249 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fu Song Xian Zhong Yao Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Eli Lilly and Company | 12 | 1 | 0 |
| 3 | AstraZeneca AB | 8 | 4 | 0 |
| 4 | Ai Min Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 5 |
| 7 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 8 | Bayer AG | 5 | 2 | 0 |
| 9 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 10 | Hangzhou Nuo Ao Biopharmaceuticals Technology Co., Ltd. romanized | 5 | 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
150 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/10Import · Class 2.2 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500150 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/12/10Import · Class 2.2 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2500149 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2025/12/10Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2504249 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. |
| 2025/12/10Generic · Class 3 | Progesterone InjectionCYHS2504239 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2025/12/10Generic · Class 3 | Progesterone InjectionCYHS2504238 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2025/12/10Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2504237 | Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | 阴道用乳杆菌二联活菌胶囊 · No verified English nameCXSS2500137 | Guangdong Long Chuang Ji Pharma Co., Ltd. romanized |
| 2025/12/10New drug · Class 1.1 | 发热伴血小板减少综合征灭活疫苗(Vero细胞) · No verified English nameCXSL2501069 | Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized |
| 2025/12/10New drug · Class 3.2 | 人凝血因子IX · No verified English nameCXSL2501068 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | WGc-043注射液 · No verified English nameCXSL2501067 | Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | WGc-043注射液 · No verified English nameCXSL2501066 | Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | KSD-101注射液 · No verified English nameCXSL2501064 | Zhong Shan Heng Sai Bio Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | KL0011034注射液 · No verified English nameCXHL2501370 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized |
| 2025/12/10New drug · Class 2.2 | TH202266胶束注射液 · No verified English nameCXHL2501363 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | PSTB100片 · No verified English nameCXHL2501362 | Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | PSTB100片 · No verified English nameCXHL2501361 | Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | PSTB100片 · No verified English nameCXHL2501360 | Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2501359 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2501358 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | GT919胶囊 · No verified English nameCXHL2501357 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2501356 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2501355 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | ADX-324注射液 · No verified English nameCXHL2501354 | Yuan Yi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | LWP779片 · No verified English nameCXHL2501353 | Yuan Sen Pharmaceutical (Hangzhou) Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | LWP779片 · No verified English nameCXHL2501352 | Yuan Sen Pharmaceutical (Hangzhou) Co., Ltd. romanized |
| 2025/12/10New drug · Class 2.4 | GEN-725片 · No verified English nameCXHL2501351 | Henan Zhen Shi Bio Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 2.4 | GEN-725片 · No verified English nameCXHL2501350 | Henan Zhen Shi Bio Technology Co., Ltd. romanized |
| 2025/12/10New drug · Class 1 | 注射用莱古比星 · No verified English nameCXHL2501349 | Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized |
| 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 |
120 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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