YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 232 drug applications between 16 November 2021 and 22 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 26 drug names.
2021/11/16 – 2021/11/22
- New acceptances this week
- 232
- Drugs with new generic filings (by drug name, de-duplicated)
- 26
- 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
232filings, 38 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 117 |
| Generic | 38 |
| New drug | 37 |
| Import | 22 |
| Import re-registration | 11 |
| Unspecified | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 175 |
| Therapeutic biologic | 27 |
| TCM | 25 |
| Biologic | 3 |
| 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
26 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 | Sildenafil Citrate Oral Disintegrating Tablets | 2 | 2 | 8 |
| 3 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 4 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 5 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 6 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 7 | Tolvaptan Tablets | 2 | 1 | 0 |
| 8 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 9 | Aminophylline Injection | 2 | 1 | 3 |
| 10 | Cytarabine for Injection | 2 | 1 | 2 |
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
140 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 3 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Upjohn Manufacturing Ireland Unlimited | 6 | 1 | 0 |
| 5 | Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Upjohn US 2 LLC | 4 | 1 | 0 |
| 8 | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 3 | 2 | 0 |
| 10 | Ji Chuan Pharma Group Co., Ltd. romanized | 3 | 2 | 3 |
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
64 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/22Import · Class 3.1 | 赖脯胰岛素注射液 · No verified English nameJXSS2101032 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/11/22Import · Class 3.1 | 赖脯胰岛素注射液 · No verified English nameJXSS2101031 | Eli Lilly Nederland B.V.; Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2021/11/22Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101135 | Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2021/11/22Import · Class 2.4 | Alectinib Hydrochloride CapsulesJXHL2101246 | F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2021/11/22Import · Class 2.4 | Alectinib Hydrochloride CapsulesJXHL2101245 | F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd. |
| 2021/11/22Generic · Class 3 | Oxytocin InjectionCYHS2102059 | Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101434 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2021/11/22New drug · Class 2.2 | 重组人源化抗VEGF单克隆抗体注射液 · No verified English nameCXSL2101433 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | 人肌母细胞注射液 · No verified English nameCXSL2101432 | Luo Gai Ji Mu Xi Bao Yi Xue Research Institute Wuhan Co., Ltd. romanized |
| 2021/11/22New drug · Class 2.2 | 注射用全氟丙烷人血白蛋白微球 · No verified English nameCXSL2101431 | Xiamen Li Zhuo Pharma Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | AK115注射液 · No verified English nameCXSL2101430 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | AK115注射液 · No verified English nameCXSL2101429 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | 注射用IAP0971 · No verified English nameCXSL2101428 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | SHR7280片 · No verified English nameCXHL2101679 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | SHR7280片 · No verified English nameCXHL2101678 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | 注射用SYHA1908 · No verified English nameCXHL2101677 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/11/22New drug · Class 1 | HZ010注射液 · No verified English nameCXHL2101676 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/19Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2102028 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/11/19New drug · Class 3.2 | 人抗凝血酶Ⅲ · No verified English nameCXSS2101053 | Shandong Tai Bang Bio Zhi Pin Co., Ltd. romanized |
| 2021/11/19New drug · Class 1 | 泰特利单抗注射液 · No verified English nameCXSS2101052 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/19New drug · Class 1 | 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2101427 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/19New drug · Class 1 | FZJ-003胶囊 · No verified English nameCXHL2101675 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/19New drug · Class 1 | BPI-442096片 · No verified English nameCXHL2101669 | Bei Da Pharma Co., Ltd. romanized |
| 2021/11/19New drug · Class 1 | BPI-442096片 · No verified English nameCXHL2101668 | Bei Da Pharma Co., Ltd. romanized |
| 2021/11/19New drug · Class 1 | HS301片 · No verified English nameCXHL2101667 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2021/11/19New drug · Class 1 | HS301片 · No verified English nameCXHL2101666 | Han Hui Pharmaceutical Co., Ltd. romanized |
| 2021/11/18Import · Class 1 | 司柏索利单抗注射液 · No verified English nameJXSS2101030 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/11/18Import · Class 1 | 注射用Dapirolizumab Pegol单抗 · No verified English nameJXSL2101134 | UCB Biopharma SRL; UCB trading (Shanghai) Co. Ltd |
| 2021/11/18Generic · Class 3 | Aminophylline InjectionCYHS2102047 | Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized |
| 2021/11/18Generic · Class 3 | Aminophylline InjectionCYHS2102046 | Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Shandong Xi Er Kang Tai Pharma Co., Ltd. romanized |
34 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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