YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 96 drug applications between 30 April 2021 and 6 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 9, covering 8 drug names.
2021/04/30 – 2021/05/06
- New acceptances this week
- 96
- Drugs with new generic filings (by drug name, de-duplicated)
- 8
- 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
96filings, 9 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 62 |
| New drug | 16 |
| Generic | 9 |
| Import | 5 |
| Unspecified | 2 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 47 |
| TCM | 34 |
| Therapeutic biologic | 14 |
| Prophylactic 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
8 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Alfacalcidol Tablets | 2 | 1 | 1 |
| 2 | Diacerein Capsules | 1 | 1 | 3 |
| 3 | Olanzapine Tablets | 1 | 1 | 4 |
| 4 | Tenofovir alafenamide Fumarate Tablets | 1 | 1 | 0 |
| 5 | Sodium Hyaluronate Eye Drops | 1 | 1 | 30 |
| 6 | Ambroxol Hydrochloride Injection | 1 | 1 | 9 |
| 7 | Valsartan Film-Coated Tablets | 1 | 1 | 0 |
| 8 | Apixaban 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
53 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized | 21 | 21 | 0 |
| 2 | Eli Lilly Nederland B.V. | 5 | 3 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 4 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 5 | Xian Sen Ge Pharma Co., Ltd. romanized | 3 | 2 | 0 |
| 6 | Fujian Tian Quan Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 7 | Xizang Qi Zheng Zang Yao Co., Ltd. romanized | 3 | 1 | 0 |
| 8 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 2 | 2 | 0 |
| 9 | GlaxoSmithKline Trading Services Limited | 2 | 1 | 0 |
| 10 | Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized | 2 | 1 | 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
20 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/05/06Import · Class 1 | Efgartigimod注射液 · No verified English nameJXSL2101018 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2021/05/06New drug · Class 1 | BAT6005注射液 · No verified English nameCXSL2101052 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/05/06New drug · Class 1 | AZD4205胶囊 · No verified English nameCXHL2101102 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2021/05/06New drug · Class 1 | AZD4205胶囊 · No verified English nameCXHL2101101 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2021/05/06New drug · Class 2.2 | 雷美替胺双释片 · No verified English nameCXHL2101100 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2021/05/06New drug · Class 1 | 注射用硝酮嗪 · No verified English nameCXHL2101099 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2021/04/30Import · Class 1 | GSK3196165 注射液 · No verified English nameJXSL2101020 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2021/04/30Import · Class 1 | GSK3196165 注射液 · No verified English nameJXSL2101019 | GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Co. LTD |
| 2021/04/30Import · Class 1 | RRx-001注射液 · No verified English nameJXHL2101021 | EpicentRx Inc.; SciClone Pharmaceuticals (China) Co. Ltd. |
| 2021/04/30New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101051 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/04/30New drug · Class 3.3 | 重组抗CD20人鼠嵌合单克隆抗体注射液 · No verified English nameCXSL2101050 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | IBI360 · No verified English nameCXSL2101044 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2101098 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2101097 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2101096 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2101095 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2101094 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | BGB-11417薄膜包衣片 · No verified English nameCXHL2101093 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | ET0038片 · No verified English nameCXHL2101091 | Shanghai Yi Tuo Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/04/30New drug · Class 1 | ET0038片 · No verified English nameCXHL2101090 | Shanghai Yi Tuo Pharmaceuticals Technology 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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