YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 282 drug applications between 5 December 2021 and 11 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 42 drug names.
2021/12/05 – 2021/12/11
- New acceptances this week
- 282
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 0
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
282filings, 51 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 160 |
| Generic | 51 |
| New drug | 41 |
| Import | 14 |
| Import re-registration | 11 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| TCM | 46 |
| Therapeutic biologic | 46 |
| Prophylactic 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
42 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 阿普米司特片 · No verified English name | 3 | 1 | 3 |
| 2 | Tofacitinib Citrate Tablets | 2 | 2 | 1 |
| 3 | Candesartan Cilexetil and Hydrochlorothiazide Tablets | 2 | 1 | 0 |
| 4 | Rifampin For Injection | 2 | 1 | 2 |
| 5 | Guanfacine Hydrochloride Extended Release Tablets | 2 | 1 | 4 |
| 6 | Valsartan Film-Coated Tablets | 2 | 1 | 0 |
| 7 | Carbocisteine Oral Solution | 2 | 1 | 6 |
| 8 | Febuxostat Tablets | 2 | 1 | 12 |
| 9 | Acetylcysteine Effervescent Tablets | 1 | 1 | 3 |
| 10 | Tadalafil Tablets | 1 | 1 | 23 |
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
160 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hua Run Shuang He Pharma Co., Ltd. romanized | 15 | 14 | 0 |
| 2 | Da Lian Jin Ding Chang Pharmaceuticals Technology Co., Ltd. romanized | 11 | 11 | 0 |
| 3 | Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 4 | medac Gesellschaft für klinische Spezialpr?parate mbH | 8 | 1 | 0 |
| 5 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 6 | Shaanxi Chang Ming Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Ha Yao Group Zhong Yao Er Factory romanized | 5 | 4 | 0 |
| 8 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 9 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 4 | 2 | 1 |
| 10 | Shenzhen Shi Ling Fang Biopharmaceuticals 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
59 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/10Import · Class 3.1 | Tisotumab Vedotin · No verified English nameJXSL2101146 | Seagen Inc.; PRA Health Sciences China Inc. |
| 2021/12/10New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2101475 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2021/12/10New drug · Class 1 | THZ0106注射液 · No verified English nameCXSL2101473 | Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2021/12/10New drug · Class 1 | 人源化抗人 IgE 单克隆抗体注射液 · No verified English nameCXSL2101472 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/12/10New drug · Class 1 | BC0306胶囊 · No verified English nameCXHL2101733 | Shandong Dan Hong Pharmaceutical Co., Ltd. romanized |
| 2021/12/10New drug · Class 1 | BC0306胶囊 · No verified English nameCXHL2101732 | Shandong Dan Hong Pharmaceutical Co., Ltd. romanized |
| 2021/12/10New drug · Class 1 | LF0397片 · No verified English nameCXHL2101716 | Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/10New drug · Class 1 | LF0397片 · No verified English nameCXHL2101715 | Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/09Import · Class 1 | 人同种异体骨髓来源的成骨细胞 · No verified English nameJXSL2101145 | Bone Therapeutics SA; SHENZHEN PREGENE BIOPHARMA CO. LTD |
| 2021/12/09Generic · Class 3 | Lansoprazole For InjectionCYHS2102174 | Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized |
| 2021/12/09Generic · Class 3 | Carbocisteine Oral SolutionCYHS2102169 | Beijing Yi Jia Xin Chuang Medical Devices Technology Research Institute Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2021/12/09Generic · Class 3 | Carbocisteine Oral SolutionCYHS2102168 | Beijing Yi Jia Xin Chuang Medical Devices Technology Research Institute Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2021/12/09New drug · Class 1.1 | 全三七片 · No verified English nameCXZL2101039 | Yunnan Bai Yao Group Co., Ltd. romanized |
| 2021/12/09New drug · Class 1 | 注射用CU-20401 · No verified English nameCXSL2101474 | Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized |
| 2021/12/09New drug · Class 1 | KF-0210片 · No verified English nameCXHL2101731 | Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/09New drug · Class 1 | KF-0210片 · No verified English nameCXHL2101730 | Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2021/12/08Generic · Class 3 | Pregabalin Oral SolutionCYHS2102160 | Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized; Bao Ding Ai Hui Pharma Co., Ltd. romanized |
| 2021/12/08Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2102158 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized |
| 2021/12/08Generic · Class 3 | Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2102157 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized |
| 2021/12/08Generic · Class 3 | Nicorandil for InjectionCYHS2102156 | Chengdu Easton Biopharmaceuticals Co.,Ltd.; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | HB0028注射液 · No verified English nameCXSL2101471 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | KN060注射液 · No verified English nameCXSL2101468 | Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | LNF1904 · No verified English nameCXSL2101466 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | QY201片 · No verified English nameCXHL2101729 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | QY201片 · No verified English nameCXHL2101728 | Qi Yuan Bio (Hangzhou) Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | 盐酸BGB-23339薄膜包衣片 · No verified English nameCXHL2101727 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | 盐酸BGB-23339薄膜包衣片 · No verified English nameCXHL2101726 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | PRJ1-3024胶囊 · No verified English nameCXHL2101725 | Zhuhai Yu Fan Bio Technology Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | SAL0114片 · No verified English nameCXHL2101724 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2021/12/08New drug · Class 1 | SAL0114片 · No verified English nameCXHL2101723 | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
29 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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