YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 190 drug applications between 8 April 2021 and 14 April 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 18, covering 17 drug names.
2021/04/08 – 2021/04/14
- New acceptances this week
- 190
- Drugs with new generic filings (by drug name, de-duplicated)
- 17
- 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
190filings, 18 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| New drug | 25 |
| Generic | 18 |
| Import | 18 |
| Unspecified | 3 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 135 |
| Therapeutic biologic | 37 |
| TCM | 9 |
| Prophylactic biologic | 8 |
| Biologic | 1 |
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
17 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 小儿复方氨基酸注射液(20AA) · No verified English name | 2 | 1 | 2 |
| 2 | Doxofylline Injection | 1 | 1 | 5 |
| 3 | Tenofovir alafenamide Fumarate Tablets | 1 | 1 | 0 |
| 4 | Levofloxacin and Sodium Chloride Injection | 1 | 1 | 14 |
| 5 | Levofloxacin Injection | 1 | 1 | 1 |
| 6 | Pentoxifylline Injection | 1 | 1 | 3 |
| 7 | Dutasteride Soft Capsules | 1 | 1 | 0 |
| 8 | Leflunomide Tablets | 1 | 1 | 1 |
| 9 | 欧米加-3-酸乙酯90软胶囊 · No verified English name | 1 | 1 | 0 |
| 10 | Terlipressin for Injection | 1 | 1 | 1 |
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
91 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 40 | 18 | 0 |
| 2 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized | 9 | 1 | 0 |
| 3 | Merck Sharp & Dohme Corp. | 4 | 2 | 0 |
| 4 | Janssen-Cilag International NV | 4 | 1 | 0 |
| 5 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc | 4 | 1 | 0 |
| 6 | Ke Xing Biopharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Novartis Pharma AG | 3 | 2 | 0 |
| 8 | Beijing Foyou Pharma CO.,LTD | 3 | 2 | 1 |
| 9 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Shanxi Kang Bao Bio Zhi Pin Co., Ltd. romanized | 3 | 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
46 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/04/14Import · Class 1 | Efgartigimod注射液 · No verified English nameJXSL2101010 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/04/14Import · Class 1 | Efgartigimod注射液 · No verified English nameJXSL2101009 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/04/14Import · Class 2.2 | Benralizumab注射液 · No verified English nameJXSL2101008 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/04/14Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2101059 | Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized |
| 2021/04/14Generic · Class 3 | Leflunomide TabletsCYHS2101058 | Mei Luo Pharma Co., Ltd. romanized |
| 2021/04/14New drug · Class 2.4 | 甲磺酸伏美替尼片 · No verified English nameCXHL2101030 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/12Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101007 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2021/04/12New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101023 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/12New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101022 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/12New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101021 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/12New drug · Class 1 | SKB336注射液 · No verified English nameCXSL2101020 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/12New drug · Class 1 | D-0120-NA片 · No verified English nameCXHL2101029 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/04/12New drug · Class 1 | KL280006注射液 · No verified English nameCXHL2101028 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/12New drug · Class 1 | KL280006注射液 · No verified English nameCXHL2101027 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/04/12New drug · Class 2.4 | Lenvatinib Mesilate CapsulesCXHL2101026 | Xian Sheng Pharma Co., Ltd. romanized |
| 2021/04/10Import · Class 3.1 | 奥马珠单抗注射液 · No verified English nameJXSS2101003 | Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd. |
| 2021/04/10Import · Class 3.1 | 奥马珠单抗注射液 · No verified English nameJXSS2101002 | Novartis Europharm Limited; Vetter Pharma-Fertigung GmbH & Co. KG; Beijing Novartis Pharma Co. Ltd. |
| 2021/04/10Import · Class 1 | BI655130注射液 · No verified English nameJXSL2101006 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/04/10Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2101008 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/04/10Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2101007 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/04/10Generic · Class 3 | 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2101053 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2021/04/10Generic · Class 3 | 小儿复方氨基酸注射液(20AA) · No verified English nameCYHS2101052 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized |
| 2021/04/10Generic · Class 3 | Pentoxifylline InjectionCYHS2101051 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/04/10Generic · Class 3 | Levofloxacin InjectionCYHS2101048 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2021/04/10Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2101046 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/04/10Generic · Class 3 | 欧米加-3-酸乙酯90软胶囊 · No verified English nameCYHS2101042 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/04/10New drug · Class 1.2 | 阿可拉定软胶囊 · No verified English nameCXZS2101001 | Name not romanized; Beijing Kang Er Fu Pharma Co., Ltd. romanized |
| 2021/04/10New drug · Class 1.2 | 阿可拉定 · No verified English nameCXZS2101000 | Name not romanized |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101018 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/10New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2101017 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
16 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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