YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 172 drug applications between 27 April 2021 and 3 May 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 18, covering 17 drug names.
2021/04/27 – 2021/05/03
- New acceptances this week
- 172
- 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
172filings, 18 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 103 |
| New drug | 33 |
| Generic | 18 |
| Import | 10 |
| Import re-registration | 7 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 116 |
| TCM | 31 |
| Therapeutic biologic | 24 |
| 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
17 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 | Risperidone Oral Solution | 1 | 1 | 6 |
| 3 | Diacerein Capsules | 1 | 1 | 3 |
| 4 | Montelukast Sodium Chewable Tablets | 1 | 1 | 4 |
| 5 | Tenofovir alafenamide Fumarate Tablets | 1 | 1 | 0 |
| 6 | Lacosamide Oral Solution | 1 | 1 | 0 |
| 7 | Lansoprazole For Injection | 1 | 1 | 3 |
| 8 | 溴莫尼定噻吗洛尔滴眼液 · No verified English name | 1 | 1 | 2 |
| 9 | Sodium Hyaluronate Eye Drops | 1 | 1 | 30 |
| 10 | Lenvatinib Mesilate Capsules | 1 | 1 | 4 |
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
103 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Tian Qi Zhong Meng Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Xian Jing Xi Shuang He Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 5 | 5 | 1 |
| 4 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 2 | 0 |
| 5 | Hebei Tian Zhi Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 6 | Janssen-Cilag International NV | 4 | 2 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Nei Menggu Meng He Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 3 | 3 | 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
43 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2021/04/28Generic · Class 3 | Tirofiban Hydrochloride InjectionCYHS2101113 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized |
| 2021/04/28New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101048 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/04/28New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101047 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/04/28New drug · Class 2.2 | 西罗莫司滴眼液 · No verified English nameCXHL2101092 | Fuzhou Hao Ji Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2021/04/27Import · Class 1 | Cetrelimab · No verified English nameJXSL2101017 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/04/27Import · Class 1 | 泽弗利单抗注射液 · No verified English nameJXSL2101015 | Agenus Inc.; Betta Pharmaceuticals Co. Ltd. |
| 2021/04/27Import · Class 2.2 | TAR-200 · No verified English nameJXHL2101020 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/04/27Import · Class 2.4 | Selpercatinib胶囊 · No verified English nameJXHL2101019 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/04/27Import · Class 2.4 | Selpercatinib胶囊 · No verified English nameJXHL2101018 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/04/27Generic · Class 3 | Lansoprazole For InjectionCYHS2101110 | Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101046 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | GNC-035四特异性抗体注射液 · No verified English nameCXSL2101045 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2101043 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | 重组抗IL-1β人源化单克隆抗体注射液 · No verified English nameCXSL2101042 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | CAN106注射液 · No verified English nameCXSL2101041 | Nuo Ai Pharma (Shanghai) Co., Ltd. romanized |
| 2021/04/27New drug · Class 1 | EX103注射液 · No verified English nameCXSL2101037 | Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized |
13 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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