YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 342 drug applications between 26 February 2025 and 4 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 61 drug names.
2025/02/26 – 2025/03/04
- New acceptances this week
- 342
- Drugs with new generic filings (by drug name, de-duplicated)
- 61
- Accepted this week, now under review
- 9
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
342filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 196 |
| Generic | 76 |
| New drug | 50 |
| Import | 8 |
| Import re-registration | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 215 |
| TCM | 80 |
| Therapeutic biologic | 39 |
| Prophylactic biologic | 7 |
| Biologic | 1 |
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
61 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oxaliplatin Injection | 3 | 1 | 4 |
| 2 | Acetylcysteine Granules | 2 | 1 | 4 |
| 3 | Lactulose Oral Solution | 2 | 1 | 34 |
| 4 | Ibrutinib Tablets | 2 | 1 | 0 |
| 5 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 6 | Famotidine Injection | 2 | 1 | 8 |
| 7 | Cefuroxime Sodium for Injection | 2 | 1 | 8 |
| 8 | Lysine Acetylsalicylate For Injection | 2 | 1 | 8 |
| 9 | 盐酸丙卡特罗吸入溶液 · No verified English name | 2 | 1 | 3 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
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
192 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 24 | 22 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 14 | 3 | 0 |
| 3 | Guizhou San Ren Tang Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Bayer AG | 8 | 1 | 0 |
| 5 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 6 | Shanghai Bei Jie Group Guan Dong Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 8 | Heilongjiang Han Hong Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Merck Sharp & Dohme B.V. | 4 | 2 | 0 |
| 10 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized | 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
99 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/03/04Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSS2500021 | Horizon Therapeutics Ireland DAC; AstraZeneca Nijmegen B.V.; Changzhou Hansoh Pharmaceutical Co. Ltd. |
| 2025/03/04Import · Class 1 | PIT565 · No verified English nameJXSL2500029 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/03/04Generic · Class 3 | Famotidine InjectionCYHS2500914 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Famotidine InjectionCYHS2500913 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2500910 | TC Pharmaceuticals (Jiangsu) Co., Ltd |
| 2025/03/04Generic · Class 3 | Aceclofenac TabletsCYHS2500909 | Hefei Ying Tai Pharmaceutical Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Eltrombopag Lamine For Oral SuspensionCYHS2500908 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2025/03/04Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2500905 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2025/03/04Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2500904 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized |
| 2025/03/04Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2500903 | Kang Pu Pharma Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | 注射用BGB-B455 · No verified English nameCXSL2500198 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | NTB003注射液 · No verified English nameCXSL2500197 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2025/03/04New drug · Class 1 | REGEND003细胞自体回输制剂 · No verified English nameCXSL2500196 | Shanghai Ji Rui Yi Xue Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | 皮炎诊断贴剂02贴 · No verified English nameCXSL2500195 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | 皮炎诊断贴剂02贴 · No verified English nameCXSL2500194 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | 皮炎诊断贴剂02贴 · No verified English nameCXSL2500193 | Zhejiang Wo Wu Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | FB1002重组人源化单克隆抗体注射液 · No verified English nameCXSL2500192 | Fu Bei Biopharmaceuticals Technology (Beijing) Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | 注射用FP008 · No verified English nameCXSL2500191 | Zhuhai Fei Peng Pharmaceutical Co., Ltd. romanized |
| 2025/03/04New drug · Class 1.1 | 6价B族链球菌结合疫苗 · No verified English nameCXSL2500190 | Suzhou Ju Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500242 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500241 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500240 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500239 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | SGB-3383注射液 · No verified English nameCXHL2500238 | Suzhou Sheng Yin Biopharmaceuticals Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500237 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500236 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500235 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/04New drug · Class 1 | MWN109片 · No verified English nameCXHL2500234 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2025/03/03Generic · Class 3 | 醋酸地非法林注射液 · No verified English nameCYHS2500902 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2025/03/03Generic · Class 3 | 头孢地尼干混悬剂 · No verified English nameCYHS2500901 | Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma 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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