YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 285 drug applications between 19 January 2022 and 25 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 48 drug names.
2022/01/19 – 2022/01/25
- New acceptances this week
- 285
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- 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
285filings, 68 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 153 |
| Generic | 68 |
| New drug | 35 |
| Import | 15 |
| Import re-registration | 8 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 192 |
| TCM | 48 |
| Therapeutic biologic | 37 |
| Prophylactic biologic | 8 |
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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rivaroxaban Tablets | 3 | 1 | 3 |
| 2 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 3 | 1 | 12 |
| 3 | 氧 · No verified English name | 2 | 2 | 15 |
| 4 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 5 | Tadalafil Tablets | 2 | 1 | 23 |
| 6 | Enoxaparin Sodium Injection | 2 | 1 | 16 |
| 7 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 8 | Perampanel Tablets | 2 | 1 | 2 |
| 9 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 1 | 23 |
| 10 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
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
157 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 13 | 6 | 0 |
| 2 | Guangxi Di Tai Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | Hubei Tai Zi Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 4 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 8 | 7 | 0 |
| 5 | Xian Le Xi Medical Technology Co., Ltd. romanized | 6 | 6 | 6 |
| 6 | Diao Yu Tai Pharmaceuticals Group Jilin Tian Qiang Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 8 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hubei Rui Ze Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc | 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
66 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/01/25Import · Class 1 | MK-7684A注射液 · No verified English nameJXSL2200012 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2022/01/25Import · Class 3.1 | 司库奇尤单抗注射液 · No verified English nameJXSL2200011 | Novartis Pharma Schweiz AG; Beijing Novartis Pharma Co. Ltd. |
| 2022/01/25Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2200183 | Zhong Run Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2022/01/25Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200176 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2022/01/25Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2200175 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | 注射用QLS21908 · No verified English nameCXSL2200047 | Qilu Pharmaceutical Co., Ltd. |
| 2022/01/25New drug · Class 1 | IBI324 · No verified English nameCXSL2200046 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | 重组人IL12/15单纯疱疹I型双调控溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200045 | Shanghai Fu Nuo Jian Bio Technology Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200044 | Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2200043 | Qilu Pharmaceutical Co., Ltd. |
| 2022/01/25New drug · Class 3.3 | 重组乙型肝炎疫苗(汉逊酵母) · No verified English nameCXSL2200032 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | TT-01688-CL片 · No verified English nameCXHL2200049 | Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | ASC60片 · No verified English nameCXHL2200048 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | ASC60片 · No verified English nameCXHL2200047 | Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | D-1553片 · No verified English nameCXHL2200046 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/01/25New drug · Class 1 | D-1553片 · No verified English nameCXHL2200045 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/01/25New drug · Class 2.2 | SBK003注射液 · No verified English nameCXHL2200040 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/01/24Import · Class 1 | MK-6024注射液 · No verified English nameJXSL2200014 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2022/01/24Import · Class 1 | MK-6024注射液 · No verified English nameJXSL2200013 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2022/01/24Import · Class 1 | 注射用3D-189 · No verified English nameJXHL2200026 | 3D Medicines Inc.; 3D Medicines(Qingdao)Co. Limited |
| 2022/01/24Generic · Class 3 | Fudosteine oral solutionCYHS2200169 | Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2022/01/24Generic · Class 3 | Fudosteine oral solutionCYHS2200168 | Zhejiang Guo Jing Pharma Co., Ltd. romanized |
| 2022/01/24Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2200155 | Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/01/24Generic · Class 3 | Aripiprazole Oral SolutionCYHS2200104 | Chengdu Easton Biopharmaceuticals Co.,Ltd.; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2022/01/24Generic · Class 3 | Aripiprazole Oral SolutionCYHS2200103 | Chengdu Easton Biopharmaceuticals Co.,Ltd.; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2022/01/24Generic · Class 3 | Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release TabletsCYHS2200102 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2022/01/24Generic · Class 3 | Lidocaine CataplasmsCYHL2200009 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd |
| 2022/01/24New drug · Class 1 | CM313注射液 · No verified English nameCXSL2200042 | Kang Nuo Ya Biopharmaceuticals Technology (Chengdu) Co., Ltd. romanized |
| 2022/01/24New drug · Class 1 | 注射用YK012 · No verified English nameCXSL2200041 | Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2022/01/24New drug · Class 1 | 斯鲁利单抗注射液 · No verified English nameCXSL2200040 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
36 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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