YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 314 drug applications between 26 October 2021 and 1 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 39, covering 31 drug names.
2021/10/26 – 2021/11/01
- New acceptances this week
- 314
- Drugs with new generic filings (by drug name, de-duplicated)
- 31
- 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
314filings, 39 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 165 |
| New drug | 56 |
| Generic | 39 |
| Import | 27 |
| Import re-registration | 22 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| TCM | 42 |
| Therapeutic biologic | 41 |
| Prophylactic biologic | 6 |
| 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
31 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Moxifloxacin Hydrochloride And Sodium Chloride Injection | 2 | 2 | 10 |
| 2 | Olaparib Tablets | 2 | 1 | 0 |
| 3 | Levofloxacin Eye Drops | 2 | 1 | 16 |
| 4 | Torsemide Injection | 2 | 1 | 1 |
| 5 | Pregabalin Capsules | 2 | 1 | 12 |
| 6 | Lenvatinib Mesilate Capsules | 2 | 1 | 4 |
| 7 | Oxytocin Injection | 2 | 1 | 8 |
| 8 | 酒石酸伐尼克兰片 · No verified English name | 2 | 1 | 3 |
| 9 | Acetylcysteine Granules | 1 | 1 | 4 |
| 10 | Epalrestat Tablets | 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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Novartis Pharma Schweiz AG | 6 | 3 | 0 |
| 3 | Dong E A Hua Medical Technology Co., Ltd. Pharma Branch romanized | 6 | 2 | 0 |
| 4 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | AstraZeneca AB | 5 | 3 | 0 |
| 7 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 9 | H. Lundbeck A/S | 5 | 2 | 0 |
| 10 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 5 | 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
89 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/01Import · Class 1 | DS-1062a · No verified English nameJXSL2101122 | Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD. |
| 2021/11/01Import · Class 1 | MRTX849片 · No verified English nameJXHL2101227 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/11/01Import · Class 1 | MRTX849片 · No verified English nameJXHL2101226 | Mirati Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd. |
| 2021/11/01Generic · Class 3 | Tirofiban Hydrochloride InjectionCYHS2101951 | Guangzhou Man Xiang Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2021/11/01New drug · Class 1.1 | 脑伤乐生颗粒 · No verified English nameCXZS2101005 | Shenzhen Shi Sha Song Industrial Co., Ltd. romanized; Henan Tian Fang Pharma Zhong Yao Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101405 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101404 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101403 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | GR1501注射液 · No verified English nameCXSL2101401 | Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101400 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | ASKG712注射液 · No verified English nameCXSL2101396 | Suzhou Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2101395 | Tai Zhou Han Zhong Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 2.2 | 吸附无细胞百(组分)白破联合疫苗 · No verified English nameCXSL2101393 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | HLX35 · No verified English nameCXSL2101389 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | SHR3680片 · No verified English nameCXHS2101050 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | CBP-307胶囊 · No verified English nameCXHL2101612 | Suzhou Kang Nai De Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 1 | CBP-307胶囊 · No verified English nameCXHL2101611 | Suzhou Kang Nai De Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/01New drug · Class 2.4 | Apatinib Mesylate TabletsCXHL2101607 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/10/29Import · Class 3.1 | 纳武利尤单抗注射液 · No verified English nameJXSS2101028 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd |
| 2021/10/29Import · Class 3.1 | 纳武利尤单抗注射液 · No verified English nameJXSS2101027 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd |
| 2021/10/29Generic · Class 3 | Folic Acid TabletsCYHS2101949 | Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/10/29Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101947 | Hebei Chuang Jian Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/10/29Generic · Class 3 | Epalrestat TabletsCYHS2101945 | Xian Wan Long Pharmaceutical Co., Ltd. romanized |
| 2021/10/29Generic · Class 3 | Clonidine hydrochloride extended-release tabletsCYHL2101033 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | PD-1基因定制活化T细胞注射液 · No verified English nameCXSL2101398 | Anhui Ke Dun Bio Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | 注射用MRG003 · No verified English nameCXSL2101397 | Shanghai Mei Ya Ke Bio Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 2.1; 2.2 | 注射用RF16001 · No verified English nameCXHL2101621 | Beijing Hui Li Technology Co., Ltd. romanized; Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | JMKX001899片 · No verified English nameCXHL2101620 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | JMKX001899片 · No verified English nameCXHL2101619 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101618 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
59 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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