YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 360 drug applications between 13 May 2025 and 19 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 102, covering 74 drug names.
2025/05/13 – 2025/05/19
- New acceptances this week
- 360
- Drugs with new generic filings (by drug name, de-duplicated)
- 74
- Accepted this week, now under review
- 53
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
360filings, 102 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 180 |
| Generic | 102 |
| New drug | 52 |
| Import | 18 |
| Unspecified | 5 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 241 |
| Therapeutic biologic | 60 |
| TCM | 53 |
| Prophylactic biologic | 4 |
| Biologic | 2 |
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
74 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 复方电解质醋酸钠葡萄糖注射液 · No verified English name | 4 | 2 | 22 |
| 2 | Risperidone Oral Solution | 4 | 1 | 6 |
| 3 | Calcium Acetate Oral Solution | 4 | 1 | 1 |
| 4 | Aripiprazole Oral Solution | 4 | 1 | 4 |
| 5 | Drotaverine Hydrochloride Injection | 2 | 2 | 3 |
| 6 | Metoclopramide Hydrochloride Injection | 2 | 2 | 6 |
| 7 | 维生素B12注射液 · No verified English name | 2 | 2 | 6 |
| 8 | Oxcarbazepine Tablets | 2 | 1 | 4 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 13 | 4 | 13 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 7 | 3 | 0 |
| 3 | Hong Tao Kai Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 6 | 5 | 0 |
| 5 | Sanofi Winthrop Industrie | 6 | 1 | 0 |
| 6 | Guangdong Sunho Pharmaceutical Co., Ltd. | 5 | 2 | 2 |
| 7 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 9 | Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Hainan Hai Li Pharmaceutical Co., Ltd. romanized | 4 | 4 | 1 |
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
118 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/19Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2501810 | Shanxi Pu Heng Pharmaceutical Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | CM512注射液 · No verified English nameCXSL2500397 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500396 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500395 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | SM17单克隆抗体注射液(皮下注射) · No verified English nameCXSL2500394 | Xing Lian Pharma (Suzhou) Co., Ltd. romanized |
| 2025/05/19New drug · Class 1 | CM512注射液 · No verified English nameCXSL2500391 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2025/05/19New drug · Class 2.2 | QLM2012 · No verified English nameCXHL2500489 | Qilu Pharmaceutical Co., Ltd. |
| 2025/05/19New drug · Class 2.2 | QLM2012 · No verified English nameCXHL2500488 | Qilu Pharmaceutical Co., Ltd. |
| 2025/05/17Import · Class 1 | AMG 890 · No verified English nameJXHL2500115 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/05/17Import · Class 1 | AMG 890 · No verified English nameJXHL2500114 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) Co. Ltd. |
| 2025/05/17Import · Class 2.4 | 匹妥布替尼片 · No verified English nameJXHL2500113 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/05/17Import · Class 1 | Rilzabrutinib片 · No verified English nameJXHL2500112 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/05/17Generic · Class 3 | Brivaracetam TabletsCYHS2501808 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/05/17Generic · Class 3 | Brivaracetam TabletsCYHS2501807 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2025/05/17Generic · Class 3 | Potassium Chloride Oral SolutionCYHS2501803 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized |
| 2025/05/17Generic · Class 3 | 维生素B12注射液 · No verified English nameCYHS2501802 | Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized |
| 2025/05/17Generic · Class 3 | 硝酸咪康唑乳膏 · No verified English nameCYHS2501801 | Suzhou Gao Mai Pharma Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized |
| 2025/05/17Generic · Class 3 | Zonisamide Oral SuspensionCYHS2501795 | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized |
| 2025/05/17Generic · Class 3 | 中性低钙腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2501794 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/05/17Generic · Class 3 | Amikacin Sulfate injectionCYHS2501791 | Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized |
| 2025/05/17Generic · Class 3 | Folic Acid TabletsCYHS2501789 | Anhui Sheng Ying Pharma Co., Ltd. romanized |
| 2025/05/17Generic · Class 3 | Amikacin Sulfate injectionCYHS2501788 | Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized |
| 2025/05/17New drug · Class 2.2 | 菖麻熄风颗粒 · No verified English nameCXZS2500020 | Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized |
| 2025/05/17New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500393 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/17New drug · Class 1 | SCTB14注射液 · No verified English nameCXSL2500392 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/17New drug · Class 1 | 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2500390 | Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized; Shenzhen Fu Nuo Jian Bio Technology Co., Ltd. romanized |
| 2025/05/17New drug · Class 1 | SCT640C注射液 · No verified English nameCXSL2500389 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/17New drug · Class 2.2 | 1536A · No verified English nameCXHL2500484 | Beijing Kang Lian Zhi Hui Technology Co., Ltd. romanized |
| 2025/05/16Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2501787 | Chongqing Sai Nuo Bio Pharma Co., Ltd. romanized |
| 2025/05/16Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2501786 | Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
88 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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