YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 124 drug applications between 1 May 2025 and 7 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 25 drug names.
2025/05/01 – 2025/05/07
- New acceptances this week
- 124
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- Accepted this week, now under review
- 6
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
124filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 68 |
| Generic | 27 |
| New drug | 25 |
| Import | 3 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 91 |
| Therapeutic biologic | 17 |
| TCM | 16 |
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
25 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Benidipine Hydrochloride Tablets | 2 | 2 | 4 |
| 2 | Baricitinib Tablets | 2 | 1 | 32 |
| 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English name | 1 | 1 | 7 |
| 4 | 二甲双胍恩格列净片(Ⅰ) · No verified English name | 1 | 1 | 7 |
| 5 | 厄贝沙坦氢氯噻嗪片 · No verified English name | 1 | 1 | 5 |
| 6 | 噻托溴铵吸入粉雾剂 · No verified English name | 1 | 1 | 2 |
| 7 | Brexpiprazole Tablets | 1 | 1 | 31 |
| 8 | Fluvastatin Sodium Extended Release Tablets | 1 | 1 | 6 |
| 9 | Sacubitril Valsartan Sodium Tablets | 1 | 1 | 70 |
| 10 | 注射用阿立哌唑 · No verified English name | 1 | 1 | 4 |
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
82 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Dong Xin Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Guangdong Sunho Pharmaceutical Co., Ltd. | 5 | 1 | 0 |
| 5 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 7 | Janssen-Cilag International NV | 3 | 1 | 0 |
| 8 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized | 3 | 1 | 0 |
| 9 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 2 | 2 | 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
32 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/07Import · Class 2.2 | TARA-002 · No verified English nameJXSL2500070 | Protara Therapeutics Inc.; Syneos Health(Beijing)Inc. Ltd. |
| 2025/05/07Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2501645 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/05/07New drug · Class 1 | 重组抗CD19m-CD3抗体注射液 · No verified English nameCXSL2500355 | Tian Mai Yuan He Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/05/07New drug · Class 1 | LP-005 注射液 · No verified English nameCXSL2500354 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/05/07New drug · Class 3.4 | 注射用重组凝血因子Ⅷ(猪序列) · No verified English nameCXSL2500353 | Zhuang Ya (Beijing) Bio Technology Co., Ltd. romanized |
| 2025/05/07New drug · Class 1 | FG-B901注射液 · No verified English nameCXSL2500352 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2025/05/07New drug · Class 3.3 | HWS111注射液 · No verified English nameCXSL2500351 | Hubei Biopharmaceuticals Industry Technology Research Institute Co., Ltd. romanized |
| 2025/05/07New drug · Class 1 | CMS-D001片 · No verified English nameCXHL2500442 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/07New drug · Class 1 | CMS-D001片 · No verified English nameCXHL2500441 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/07New drug · Class 1 | CMS-D001片 · No verified English nameCXHL2500440 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/07New drug · Class 1 | 纳米氧化铁注射液 · No verified English nameCXHL2500439 | Suzhou Xin Ying Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/07New drug · Class 2.2 | YH2201干混悬剂 · No verified English nameCXHL2500438 | Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized |
| 2025/05/07New drug · Class 2.2 | YH2201干混悬剂 · No verified English nameCXHL2500437 | Zhejiang Yi Han Pharmaceutical Co., Ltd. romanized |
| 2025/05/06Import · Class 2.4 | Tacrolimus Eye DropsJXHL2500104 | SENJU PHARMACEUTICAL CO. LTD.; Name not romanized |
| 2025/05/01Import · Class 1 | 177Lu-HuJ591单抗注射液 · No verified English nameJXSL2500069 | Telix Pharmaceuticals (Innovations) Pty Ltd; GrandPharma (China) Co. Ltd. |
| 2025/05/01Generic · Class 3 | Sevelamer Carbonate Powder for oral suspensionCYHS2501638 | Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2025/05/01Generic · Class 3 | Meloxicam injectionCYHS2501635 | Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized |
| 2025/05/01Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2501634 | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2025/05/01New drug · Class 1 | FL115注射液 · No verified English nameCXSL2500350 | Suzhou Fu Rong Bio Technology Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | BAT4406F注射液 · No verified English nameCXSL2500349 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2500348 | Shenzhen Shi Bei Ke Bio Technology Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 注射用BGB-B3227 · No verified English nameCXSL2500347 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 注射用重组病毒巨噬细胞炎性蛋白 · No verified English nameCXSL2500346 | Guangzhou Hong Run Bio Technology Co., Ltd. romanized |
| 2025/05/01New drug · Class 2.2 | 依沃西单抗注射液 · No verified English nameCXSL2500345 | Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | 注射用HRS8179 · No verified English nameCXHL2500436 | Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500435 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500434 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500433 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | MDI-1228_mesylate凝胶 · No verified English nameCXHL2500432 | Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized |
| 2025/05/01New drug · Class 1 | HRS-1893片 · No verified English nameCXHL2500431 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
2 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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