YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 352 drug applications between 10 December 2025 and 16 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 52 drug names.
2025/12/10 – 2025/12/16
- New acceptances this week
- 352
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 97
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
352filings, 71 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 169 |
| New drug | 81 |
| Generic | 71 |
| Import re-registration | 13 |
| Unspecified | 9 |
| Import | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 75 |
| Therapeutic biologic | 54 |
| Prophylactic biologic | 5 |
| 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
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 4 | 2 | 34 |
| 2 | Mirogabalin Besilate Tablets | 4 | 1 | 61 |
| 3 | Pregabalin Capsules | 3 | 1 | 12 |
| 4 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 5 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
| 6 | Ceftazidime And Avibactam Sodium For Injection | 2 | 1 | 12 |
| 7 | 注射用托伐普坦磷酸钠 · No verified English name | 2 | 1 | 15 |
| 8 | Safinamide Methansulfonate Tablets | 2 | 1 | 20 |
| 9 | Chloroprocaine Hydrochloride Injection | 2 | 1 | 10 |
| 10 | Minoxidil Liniment | 2 | 1 | 52 |
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
220 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 6 | 6 | 0 |
| 2 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 3 | Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | AstraZeneca AB | 5 | 2 | 0 |
| 6 | Novo Nordisk A/S | 5 | 1 | 0 |
| 7 | Haerbin Mei Jun Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized | 4 | 4 | 3 |
| 9 | Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Janssen-Cilag International NV | 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
111 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/16Import · Class 2.2 | 罗莫索珠单抗注射液 · No verified English nameJXSL2500240 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2025/12/16Import · Class 1 | PF-07275315注射液 · No verified English nameJXSL2500239 | Pfizer Inc.; PFIZER (CHINA) RESEARCH & DEVELOPMENT CO. LTD. |
| 2025/12/16Import · Class 1 | EPX-100口服溶液 · No verified English nameJXHL2500388 | Epygenix Therapeutics Inc.; Tenacia Biotechnology (Shanghai) Co. Ltd |
| 2025/12/16Generic · Class 3 | Nystatin Oral SuspensionCYHS2504296 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/16Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2504295 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/16Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2504294 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/12/16Generic · Class 3 | Lisinopril and Hydrochlorothiazide TabletsCYHS2504293 | Jiangsu Deyuan Pharmaceutical Co.,Ltd. |
| 2025/12/16Generic · Class 3 | Potassium Chloride InjectionCYHS2504290 | Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | AT03-65 · No verified English nameCXSL2501085 | Tai Cheng Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | 注射用DB-2304 · No verified English nameCXSL2501084 | Ying En Bio Technology (Shanghai) Co., Ltd. romanized |
| 2025/12/16New drug · Class 3.2 | 改良型安卡拉痘苗病毒(MVA)猴痘减毒活疫苗 · No verified English nameCXSL2501083 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | 注射用LM-302 · No verified English nameCXSL2501082 | Li Xin Pharmaceuticals (Zhejiang) Co., Ltd. romanized; Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/12/16New drug · Class 3.3 | 帕博利珠单抗注射液 · No verified English nameCXSL2501079 | Hua Lan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | 注射用SHR-9803 · No verified English nameCXSL2501078 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Mai Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/16New drug · Class 2.2; 2.4 | GenSci141软膏 · No verified English nameCXHL2501397 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/12/16New drug · Class 2.2; 2.4 | GenSci141软膏 · No verified English nameCXHL2501396 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/12/16New drug · Class 2.2; 2.4 | GenSci141软膏 · No verified English nameCXHL2501395 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/12/16New drug · Class 2.2; 2.4 | GenSci141软膏 · No verified English nameCXHL2501394 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2025/12/16New drug · Class 2.4 | Deoxycholic Acid InjectionCXHL2501393 | Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | ABSK061胶囊 · No verified English nameCXHL2501392 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | ABSK061胶囊 · No verified English nameCXHL2501391 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | ABSK061胶囊 · No verified English nameCXHL2501390 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | ABSK043片 · No verified English nameCXHL2501389 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | RNK08954片 · No verified English nameCXHL2501388 | Name not romanized |
| 2025/12/16New drug · Class 1 | KHN707片 · No verified English nameCXHL2501387 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2025/12/16New drug · Class 1 | KHN707片 · No verified English nameCXHL2501386 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized |
| 2025/12/15Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2504283 | Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized |
| 2025/12/15Generic · Class 3 | Bempedoic Acid TabletsCYHL2500221 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2025/12/15New drug · Class 1 | GB19注射液 · No verified English nameCXSL2501081 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
| 2025/12/15New drug · Class 1 | GB19注射液 · No verified English nameCXSL2501080 | Shenzhen Ke Xing Pharma Co., Ltd. romanized |
81 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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