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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 475 drug applications between 13 May 2026 and 19 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 60 drug names.

2026/05/13 – 2026/05/19

Period
2026/05/13 to 2026/05/19, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
475
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
134

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

475filings, 92 of them generic

By application type

Application typeFilings
Supplement263
Generic92
New drug85
Import18
Import re-registration13
Unspecified4

By drug type

Drug typeFilings
Chemical drug252
TCM150
Therapeutic biologic68
Biologic3
Prophylactic biologic2

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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets6270
2Edaravone and Dexborneol Concentrated Solution for Injection3334
3瑞维那新吸入溶液 · No verified English name3353
4Brexpiprazole Tablets3131
5LevomilnacipranHydrochloride Extended-release Capsules316
6Upadacitinib Sustained-release Tablets2243
7氧(液态) · No verified English name2213
8二甲硅油乳剂 · No verified English name2114
9地氯雷他定口服溶液 · No verified English name2126
10复方醋酸钠葡萄糖注射液 · No verified English name218

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

273 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized30130
2Karuna Therapeutics Inc. a Bristol Myers Squibb Company820
3Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized710
4Hubei Dong Xin Pharma Co., Ltd. romanized660
5Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized650
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
7Kyowa Kirin Co. Ltd.610
8Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized610
9Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized550
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550

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

128 this week

AcceptedDrugApplicants
2026/05/19Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2601174 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2026/05/19Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2601173 Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2026/05/19Generic · Class 3 注射用甲钴胺 · No verified English nameCYHL2600062 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/05/19New drug · Class 1 JMB2302注射液 · No verified English nameCXSL2600549 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized; Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2026/05/19New drug · Class 1 JMB2302注射液 · No verified English nameCXSL2600548 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized; Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2026/05/19New drug · Class 1 UGX202注射液 · No verified English nameCXSL2600547 Suzhou Xing Ming You Jian Bio Technology Co., Ltd. romanized
2026/05/19New drug · Class 1 治疗用人乳头瘤病毒mRNA疫苗 · No verified English nameCXSL2600546 Rong Can Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/19New drug · Class 1 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2600545 Shanghai Jun Sai Bio Co., Ltd. romanized; Shanghai Jun Sai Bio Pharma Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600598 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600597 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600596 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600595 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600594 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600593 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 HY1770乳膏 · No verified English nameCXHL2600592 Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized
2026/05/19New drug · Class 1 ISM8969/HT-001片 · No verified English nameCXHL2600591 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized; Shenzhen Heng Tai Bio Technology Co., Ltd. romanized
2026/05/19New drug · Class 1 ISM8969/HT-001片 · No verified English nameCXHL2600590 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized; Shenzhen Heng Tai Bio Technology Co., Ltd. romanized
2026/05/18Generic · Class 3 Doxycycline Hyclate TabletsCYHS2601168 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized
2026/05/18Generic · Class 3 Doxycycline Hyclate TabletsCYHS2601167 Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized
2026/05/18Generic · Class 3 Relugolix TabletsCYHS2601163 Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized
2026/05/18Generic · Class 3 马沙骨化醇注射液 · No verified English nameCYHL2600061 Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/05/18New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600085 Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized
2026/05/18New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600084 Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized
2026/05/18New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600544 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/05/18New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2600543 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/05/18New drug · Class 1 注射用TL001 · No verified English nameCXSL2600542 Shanghai Tang Ling Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized
2026/05/18New drug · Class 1 LM-168注射液 · No verified English nameCXSL2600541 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/18New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2600540 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/05/18New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2600539 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/05/18New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2600538 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized

98 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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