YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 154 drug applications between 1 May 2026 and 7 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 13, covering 12 drug names.
2026/05/01 – 2026/05/07
- New acceptances this week
- 154
- Drugs with new generic filings (by drug name, de-duplicated)
- 12
- Accepted this week, now under review
- 30
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
154filings, 13 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 108 |
| New drug | 23 |
| Generic | 13 |
| Unspecified | 4 |
| Import | 3 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 82 |
| Chemical drug | 50 |
| Therapeutic biologic | 20 |
| 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
12 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Atosiban Acetate Injection | 2 | 1 | 2 |
| 2 | Pemafibrate Tablets | 1 | 1 | 23 |
| 3 | 噻托溴铵吸入粉雾剂 · No verified English name | 1 | 1 | 2 |
| 4 | Menatetrenone Soft Capsules | 1 | 1 | 4 |
| 5 | Deferasirox Granules | 1 | 1 | 2 |
| 6 | Levofloxacin and Sodium Chloride Injection | 1 | 1 | 14 |
| 7 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 1 | 1 | 23 |
| 8 | Amphotericin B Liposome for Injection | 1 | 1 | 2 |
| 9 | Epirubicin Hydrochloride for Injection | 1 | 1 | 2 |
| 10 | Ambroxol Hydrochloride Tablets | 1 | 1 | 3 |
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
108 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized | 12 | 8 | 0 |
| 2 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 8 | 6 | 0 |
| 3 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Qilu Pharmaceutical Co., Ltd. | 4 | 1 | 0 |
| 5 | Haerbin Tong Yi Tang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 6 | Pfizer Inc. | 3 | 2 | 0 |
| 7 | CKD Bio Corporation | 2 | 2 | 0 |
| 8 | Kashima Plant,Eisai Co. Ltd. | 2 | 2 | 0 |
| 9 | Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized | 2 | 2 | 0 |
| 10 | He Bo Pharmaceuticals (Shanghai) 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
26 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/07Import · Class 1 | 注射用Dapirolizumab Pegol单抗 · No verified English nameJXSL2600108 | UCB Biopharma SRL; UCB trading (Shanghai) Co. Ltd |
| 2026/05/07New drug · Class 1 | 注射用重组抗EpCAM 和CD3人鼠嵌合双特异性抗体 · No verified English nameCXSS2600078 | Zheng Da Tian Qing Run Xin Pharmaceuticals (Wuhan) Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | 注射用HBM2001(皮下注射) · No verified English nameCXSL2600477 | He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | 注射用HBM2001 · No verified English nameCXSL2600476 | He Bo Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/05/07New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600471 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | 注射用SHR-1501 · No verified English nameCXSL2600470 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | SHR-2005注射液 · No verified English nameCXSL2600469 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | 注射用HLX43 · No verified English nameCXSL2600468 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | HLX37注射液 · No verified English nameCXSL2600467 | Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | TT-00973-MS片 · No verified English nameCXHL2600533 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2026/05/07New drug · Class 1 | YC020滴眼液 · No verified English nameCXHL2600532 | Beijing Yi Cheng Qi Ming Technology Co., Ltd. romanized |
| 2026/05/07New drug · Class 2.2 | CB549 · No verified English nameCXHL2600529 | Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/06Generic · Class 3 | Deferasirox GranulesCYHS2601029 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/05/06Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2601024 | Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/05/06New drug · Class 1 | KHN921注射液 · No verified English nameCXSL2600466 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2026/05/06New drug · Class 2.2 | 注射用芦康沙妥珠单抗 · No verified English nameCXSL2600465 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/06New drug · Class 2.2 | 注射用芦康沙妥珠单抗 · No verified English nameCXSL2600464 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/06New drug · Class 1 | QLS1410片 · No verified English nameCXHL2600531 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/06New drug · Class 1 | QLS1410片 · No verified English nameCXHL2600530 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/06New drug · Class 1 | QLS1410片 · No verified English nameCXHL2600528 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/06New drug · Class 1 | QLS1410片 · No verified English nameCXHL2600527 | Qilu Pharmaceutical Co., Ltd. |
| 2026/05/06New drug · Class 1 | YF087片 · No verified English nameCXHL2600526 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/01New drug · Class 1.1 | 天心解郁颗粒 · No verified English nameCXZL2600039 | Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/01New drug · Class 5.1 | 多西他赛注射液(白蛋白稳定型) · No verified English nameCXHS2600061 | Zhuhai Bei Hai Bio Technology Co., Ltd. romanized; Jian Jin Pharmaceutical Co., Ltd. romanized |
| 2026/05/01New drug · Class 2.2 | 醋酸奥曲肽片 · No verified English nameCXHL2600525 | San Die Ji (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/01New drug · Class 2.2 | GCF20216 · No verified English nameCXHL2600523 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized |
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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