YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 328 drug applications between 11 December 2025 and 17 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 46 drug names.
2025/12/11 – 2025/12/17
- New acceptances this week
- 328
- Drugs with new generic filings (by drug name, de-duplicated)
- 46
- Accepted this week, now under review
- 92
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
328filings, 70 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 160 |
| New drug | 72 |
| Generic | 70 |
| Import re-registration | 12 |
| Unspecified | 8 |
| Import | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 192 |
| TCM | 76 |
| Therapeutic biologic | 53 |
| Biologic | 4 |
| Prophylactic biologic | 3 |
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
46 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 | Azilsartan Medoxomil Potassium Tablets | 4 | 2 | 35 |
| 3 | Mirogabalin Besilate Tablets | 4 | 1 | 61 |
| 4 | Pregabalin Capsules | 3 | 1 | 12 |
| 5 | Nystatin Oral Suspension | 2 | 2 | 3 |
| 6 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 7 | Divalproex Sodium Extended-Release Tablets | 2 | 1 | 0 |
| 8 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
| 9 | Losartan Potassium Tablets | 2 | 1 | 5 |
| 10 | Ceftazidime And Avibactam Sodium For Injection | 2 | 1 | 12 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 7 | 7 | 0 |
| 2 | Fresenius Kabi Austria GmbH | 6 | 1 | 0 |
| 3 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized | 5 | 3 | 0 |
| 5 | Novo Nordisk A/S | 5 | 1 | 0 |
| 6 | Pfizer Inc. | 4 | 2 | 0 |
| 7 | Shanghai He Yu Biopharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Wuhan Jiu An Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Rui Yang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/17Generic · Class 3 | Nystatin Oral SuspensionCYHS2504317 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2025/12/17Generic · Class 3 | Divalproex Sodium Extended-Release TabletsCYHL2500224 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized |
| 2025/12/17Generic · Class 3 | Divalproex Sodium Extended-Release TabletsCYHL2500223 | Shandong Xin Yi Pharmaceutical Co., Ltd. romanized |
| 2025/12/17New drug · Class 1.2 | 注射用羟基红花黄色素A · No verified English nameCXZL2500130 | Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2025/12/17New drug · Class 1.2 | 羟基红花黄色素A · No verified English nameCXZL2500129 | Xing Lin Zhong Pharmaceuticals Technology (Guangzhou) Co., Ltd. romanized |
| 2025/12/17New drug · Class 1 | 注射用DB-1324 · No verified English nameCXSL2501090 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/12/17New drug · Class 1 | JSKN027注射液 · No verified English nameCXSL2501089 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2025/12/17New drug · Class 1.2 | 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2501087 | Xiamen Wan Tai Cang Hai Bio Technology Co., Ltd. romanized; Xiamen University romanized |
| 2025/12/17New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2501086 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2025/12/17New drug · Class 2.3 | 阿瑞匹坦帕洛诺司琼乳状注射液 · No verified English nameCXHS2500157 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/12/17New drug · Class 1 | MWX401注射液 · No verified English nameCXHL2501403 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/12/17New drug · Class 1 | MDI-1228_mesylate滴眼液 · No verified English nameCXHL2501402 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/12/17New drug · Class 1 | MDI-1228_mesylate滴眼液 · No verified English nameCXHL2501401 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/12/17New drug · Class 2.2 | AZDT胶囊装微片 · No verified English nameCXHL2501400 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized |
| 2025/12/17New drug · Class 1 | HSN002066C1片 · No verified English nameCXHL2501399 | Chongqing Hua Sen Ying Nuo Bio Technology Co., Ltd. romanized |
| 2025/12/17New drug · Class 1 | HSN002066C1片 · No verified English nameCXHL2501398 | Chongqing Hua Sen Ying Nuo Bio Technology Co., Ltd. romanized |
| 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 |
69 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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