YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 179 drug applications between 3 May 2025 and 9 May 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 37 drug names.
2025/05/03 – 2025/05/09
- New acceptances this week
- 179
- Drugs with new generic filings (by drug name, de-duplicated)
- 37
- 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
179filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 80 |
| Generic | 51 |
| New drug | 38 |
| Import | 8 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 122 |
| Therapeutic biologic | 29 |
| TCM | 23 |
| Prophylactic biologic | 3 |
| 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
37 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Penicillin G Sodium For Injection | 6 | 1 | 2 |
| 2 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 3 | 黄体酮注射液(Ⅱ) · No verified English name | 2 | 2 | 2 |
| 4 | Orlistat Capsules | 2 | 1 | 8 |
| 5 | Baricitinib Tablets | 2 | 1 | 32 |
| 6 | 昂丹司琼口溶膜 · No verified English name | 2 | 1 | 2 |
| 7 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 8 | Nicardipine Hydrochloride Injection | 2 | 1 | 13 |
| 9 | Fexofenadine Hydrochloride Tablets | 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
120 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Chengdu Jing Fu Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 6 |
| 4 | Shanxi Huang He Zhong Yao Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Shanxi Mai Di Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 6 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 3 | 3 | 2 |
| 7 | AstraZeneca AB | 3 | 2 | 0 |
| 8 | Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 9 | Hainan De Mei Pharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Hefei A Fa Na Bio Technology Co., Ltd. romanized | 2 | 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
65 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/05/09Import · Class 3.1 | Risankizumab · No verified English nameJXSL2500073 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/05/09Import · Class 2.1 | Risankizumab · No verified English nameJXSL2500072 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/05/09Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2501681 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/05/09Generic · Class 3 | Fexofenadine Hydrochloride TabletsCYHS2501680 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized; Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | 注射用RC278 · No verified English nameCXSL2500368 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/05/09New drug · Class 1.2 | AFN1204注射液 · No verified English nameCXSL2500367 | Hefei A Fa Na Bio Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | IBI130 · No verified English nameCXSL2500366 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2025/05/09New drug · Class 1.2 | AFN1213注射液 · No verified English nameCXSL2500365 | Hefei A Fa Na Bio Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | SCTB39-1注射液 · No verified English nameCXSL2500364 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | 注射用VDJ006 · No verified English nameCXSL2500363 | Beijing Wei De Jie Bio Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHS2500045 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/05/09New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHS2500044 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | DEG6498胶囊 · No verified English nameCXHL2500456 | Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | DEG6498胶囊 · No verified English nameCXHL2500455 | Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | DEG6498胶囊 · No verified English nameCXHL2500454 | Hangzhou Da Ge Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 2.2 | X004口服溶液 · No verified English nameCXHL2500450 | Beijing Hai Yi Pharma Co., Ltd. romanized |
| 2025/05/09New drug · Class 2.2 | KLA318-2纳米晶注射液 · No verified English nameCXHL2500449 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | 注射用JJH201601脂质体 · No verified English nameCXHL2500448 | Jiangsu Ji Bei Er Pharma Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2500447 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2500446 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | NB001片 · No verified English nameCXHL2500445 | Zhejiang Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/09New drug · Class 1 | NB001片 · No verified English nameCXHL2500444 | Zhejiang Yong Zhan Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/05/08Import · Class 3.1 | 注射用卡普赛珠单抗 · No verified English nameJXSS2500053 | Ablynx NV; Patheon Italia S.p.A.; Sanofi (China) Investment Co. Ltd. |
| 2025/05/08Import · Class 3.4 | 人血白蛋白 · No verified English nameJXSS2500052 | CSL Behring (Australia) Pty Ltd |
| 2025/05/08Import · Class 1 | Depemokimab注射液 · No verified English nameJXSL2500071 | GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd. |
| 2025/05/08Import · Class 1 | Liafensine片 · No verified English nameJXHL2500105 | Denovo Biopharma LLC; Denovo Biopharma Co. Ltd. |
| 2025/05/08Generic · Class 3 | Minoxidil LinimentCYHS2501671 | Changsha Innovation Drug Gong Ye Technology Research Institute Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/05/08Generic · Class 3 | Minoxidil LinimentCYHS2501670 | Changsha Innovation Drug Gong Ye Technology Research Institute Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/05/08Generic · Class 3 | 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501666 | Beijing Liu Huan Pharma Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2025/05/08Generic · Class 3 | 黄体酮注射液(Ⅱ) · No verified English nameCYHS2501665 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
35 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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